Sulfuric acid, C16-C18 (even numbered) alkyl esters, sodium salts and C16-18 (even numbered) alcohols

Endpoint summary

Description of key information

Various literature data were available in rats for the acute toxicity of long chain alcohols (LCOH C14, C16, C18, C20 chains), alkyl sulfates (AS C12 chain representing worst case situation for C14-C20) and sodium sulfate. Based on concentration addition, LD50 values for the registered substance of 4702 and 2547 mg/kg bw could be calculated for acute oral and dermal toxicity, respectively. It can therefore be concluded that LD50 >2000 mg/kg bw for the oral and dermal route, and that there is no acute toxicity concern. For the inhalation route, acute toxicity testing is waived based on the low vapour pressure of the registered substance (4.1 Pa at 20°C).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Specific details on test material used for the study:

OTHER SPECIFICS:
Trade name: Texapon L 100
C12 > 98%

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 164 - 210 g

Route of administration:

oral: gavage

Vehicle:

water

No. of animals per sex per dose:

5-10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
-Other examinations performed: clinical signs, gross pathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 200 mg/kg bw

Sex:

male

Dose descriptor:

LD50

Effect level:

1 427 mg/kg bw

Sex:

female

Dose descriptor:

LD50

Effect level:

977 mg/kg bw

Mortality:

deaths within 4 - 48 hrs p.a. not further specified

Clinical signs:

other: diarrhoea, reduced activity, laboured breathing, coma

Gross pathology:

haemorrhages in gastro-intestinal tract and vascular congestion in the liver of died animals; no adverse effects in survivors

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The rat oral LD50 for males and females = 1200 mg/kg bw.
The rat oral LD50 is 1427 mg/kg bw for males and 977 mg/kg bw for females.

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study according to OECD Guideline 401 in rats.

The acute oral toxicity of Sodium dodecyl sulfate (CAS 151-21-3) was evaluated in male and female Wistar rats with single dosing via gavage (doses not further specified). Observation of clinical signs and mortality and necropsy of died animals and of survivors was performed.

Deaths were observed within 4-48 hrs post administration but no further information was given.

The clinical signs observed were: diarrhoea, reduced activity, laboured breathing, coma.

At necropsy haemorrhages in gastro-intestinal tract and vascular congestion in the liver were observed in the died animals and no adverse effects were noted in the survivors.

The rat oral LD50 for males and females = 1200 mg/kg bw.

The rat oral LD50 is 1427 mg/kg bw for males and 977 mg/kg bw for females.

 

Reference: Henkel KGaA (1983) Texapon L 100. Pruefung auf akute orale Toxizitaet an Ratten (Unpublished Report No. TBD 830021). Henkel KGaA, Duesseldorf, 2 pp.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: contract laboratory protocol

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

OTHER SPECIFICS:Tradename Alfol 14

Species:

rat

Strain:

other: COX-SD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 210-299g
- Fasting period before study: yes fasted.

Route of administration:

oral: gavage

Vehicle:

other: 1% w/w gum tragacanth

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% w/w suspension in 1% w/w gum tragacanth

MAXIMUM DOSE VOLUME APPLIED: 50% suspension highest practical dose 20 g/kg.

Doses:

7.26, 12.62, 15.89 and 20 g/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs of toxicity and death several times on the day of dosing and daily thereafter. Survivors were weighed at the end of the observation period.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 20 000 mg/kg bw

Based on:

test mat.

Mortality:

- Time of death: Observation days 5 (dose level 12.62 g/kg), 6 and 10 (dose level 20 g/kg).
- Number of deaths at each dose: 0/10, 1/10, 0/10, 2/10 all deaths were amongst females

Clinical signs:

other: Animals at each dose displayed the following: hypoactivity, diarrhea, hypersalivation, diuresis, ocular porphyrin deposits, unthriftiness, thinness, and emaciation. Surviving animals returned to normal between 1 and 10 days following dosage.

Gross pathology:

Two animals which succumbed had moderate to severe congestion of the kidneys, adrenals, liver, lungs,stomach and gastrointestinal tract, haemorrhages (1 rat), and erosion of the mucosa of the stomach. The remaining decedent was in an advanced state of autolysis and no conclusions could be drawn. Of the animals that were sacrificed, gross necropsy findings were unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for Alfol 14 is >20 g/kg.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Tetradecanol(CAS 112-72-1) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 studies according to OECD TG 401 in COX-SD and in Carworth-Wistar rats.

The study in COX-SD rats is reported here.

In this study 5 male and 5 female fasted COX-CD rats were dosed by oral gavage with Alfol 14 in dose levels of 7.26, 12.62, 15.89 and 20 g/kg bw based on a range finding test. The animals were observed for clinical signs of toxicity and death several times on the day of dosing and daily thereafter. All decedents and survivors were necropsied. Survivors were weighed at the end of the observation period. Two animals which succumbed had moderate to severe congestion of the kidneys, adrenals, liver, lungs, stomach and gastrointestinal tract, hemorrhages (1 rat), and erosion of the mucosa of the stomach. The remaining decedent was in an advanced state of autolysis and no conclusions could be drawn. Of the animals that were sacrificed, gross necropsy findings were unremarkable. Animals at all dose levels showed signs of intoxication following dosing these persisting from 1 to 10 days. Erosion of the gastric mucosa was observed in two decedents but not in survivors.

The rat oral LD50 for Alfol 14 is > 20g/kg.

(Reference: Scientific Associates, Inc. 1977. Acute oral toxicity (LD50) in rats, acute dermal toxicity (LD50) in rabbits, dermal irritation test in rabbits, eye irritation test in rabbits, and inhalation toxicity test in rats. ALFOL 14 alcohol.)

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

OTHER SPECIFICS: Tetradecanol (mixed isomers)

Species:

rat

Strain:

other: Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
Rat (Carworth-Wistar)
- Age: 5 weeks
- Fasting period before study: No, non-fasted.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

not reported

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male

Dose descriptor:

LD50

Effect level:

32.5 mL/kg bw

Based on:

test mat.

95% CL:

>= 29.1 - <= 36.5

Sex:

male

Dose descriptor:

LD50

Effect level:

26 980 mg/kg bw

Based on:

test mat.

Remarks:

assuming a density of the order of 0.83

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Tetradecanol is >32.5 mL/kg bw. Assuming a density of 0.83 this gives a LD50 of 26980 mg/kg bw.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 studies according to OECD TG 401 in COX-SD and in Carworth-Wistar rats.

The study in Carworth-Wistar rats is reported here.

In this study 5 male non- fasted Carworth-Wista rats were dosed by oral gavage with 1-Tetradecanol.

Animals at all dose levels showed signs of intoxication following dosing these persisting from 1 to 10 days. Erosion of the gastric mucosa was observed in two decedents but not in survivors. Of the animals that were sacrificed, gross necropsy findings were unremarkable

The rat oral LD50 for the mixed isomers of tetradecanol was > 32.5 mL/kg bw with confidence limits of 29.1 - 36.5 mL/kg bw. Assuming a density of the order of 0.83 (from physical data) this gives an LD50 of 26980 mg/kg bw.

References:

-Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C.,Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Am. Ind. Hyg. Assoc. J. 30(5):470-476.

-Patty's Toxicology 2001 Bevan, C. Aliphatic alcohols (Monohydric alcohols) John Wiley & Sons - on line.

-Opdyke, D.L.J. 1975 Fragrance raw material monographs -Alcohol C14 Myristic. 13(Suppl.) 699-700

 

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

OTHER SPECIFICS: Tradename Kalcol 6068.

Species:

rat

Strain:

other: Sprague-Dawley CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: Sprague-Dawley CD
- Source: Charles River, Margate, Kent, UK
- Age at study initiation: 5-8 weeks
- Weight at study initiation: males 135-145g, females 127-137g
- Fasting period before study: Yes

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

Sprague-Dawley CD rats
VEHICLE
- Concentration in vehicle: 200 mg/mL in arachis oil
- Amount of vehicle (if gavage): 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:Single dose level of 2000 mg/kg based on a range finding test.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed for clinical signs of toxicity and mortality 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the observation period. Body weights were recorded prior to dosing on day 0 and then at 7 and 14 days.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Remarks:

Sprague-Dawley CD rats

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Hempstock, C. 1996a. Kalcohl 6098: Acute oral toxicity (limit test) in the rat. SPL Project Number 140/495)

Mortality:

There were no deaths.

Clinical signs:

other: At this dose level there were no signs of toxicity.

Gross pathology:

Unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Hexadecanol (CAS 36653-82-4) (Tradename: Kalcol 6098) is > 2000 mg/kg.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Hexadecanol (CAS 36653-82-4) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 1 studies according to OECD TG 401 in Sprague-Dawley CD and in Wistar rats.

The study in Sprague-Dawley rats is reported here.

In this study 5 male and 5 female fasted Sprague-Dawley CD rats were dosed by oral gavage with Kalcol 6068 at a concentration of 200 mg/mL in arachis oil in a single dose level of 2000 mg/kg based on a range finding test.
The rats were observed for clinical signs of toxicity and mortality 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the observation period. Body weights were recorded prior to dosing on day 0 and then at 7 and 14 days. All animals were subject to gross pathological examination at the end of the observation.
There were no deaths. No clinical signs of systemic toxicity. All animals showed the expected body weight gain over the observation period. The necropsy findings were unremarkable.
The rat oral LD50 for Kalcol 6098 is > 2000 mg/kg. At this dose level there were no signs of toxicity.
(Reference: Hempstock, C. 1996. Kalcohl 6098: Acute oral toxicit (limit test) in the rat. SPL Project Number 140/495)

Reference 5

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

OTHER SPECIFICS: Tradename Lorol (Lanette) 16

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS: Wistar
- Source: : Winkelmann, Hanover, Germany
- Weight at study initiation: average body weight males 174g, females 144g.
- Fasting period before study: Yes

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% suspension in olive oil
- Amount of vehicle (if gavage): 10 mL/kg

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: : Mortality and clinical signs were recorded. Body weights were taken before dosing and at 24 hours, 1 and 2 weeks after dosing.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Remarks:

Wistar rats

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Henkel KGaA 1981c also reported in IUCLID 2000

Mortality:

All animals survived the observation period.

Clinical signs:

other: Slight sedation and piloerection were observed during the first 24 hours after dosing in all rats.

Gross pathology:

Unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Hexadecanol (CAS 36653-82-4) (Tradename: Lorol (Lanette) 16) is > 5000 mg/kg.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Hexadecanol (CAS 36653-82-4) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 1 studies according to OECD TG 401 in Sprague-Dawley CD and in Wistar rats.

The study in Wistar rats is reported here.

5 Male and 5 female fasted Wistar rats were dosed by oral gavage with Lorol (Lanette) 16 at a concentration of 50% in olive oil in a single dose level of 5000 mg/kg. Mortality and clinical signs were recorded. Body weights were taken before dosing and at 24 hours, 1 and 2 weeks after dosing. All rats were subject to gross necropsy at the end of the observation period. All animals survived the observation period. Slight sedation and piloerection were observed during the first 24 hours after dosing in all rats. The average body weight of the groups of male and female rats increased over the observation period. The necropsy findings were unremarkable. The rat oral LD50 for Lorol (Lanette) 16 is > 5000 mg/kg. Clinical signs were confined to slight sedation and piloerection in the first 24 hours after dosing.

(Reference: Henkel KGaA 1981 Hexadecanol: Evaluation of acute oral toxicity. Unpublished data, Report No. R 9500188 (944) and summary report 1999, also reported in IUCLID 2000)

Reference 6

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

OTHER SPECIFICS: Tradename Kalcol 8098

Species:

rat

Strain:

other: Sprangue-Dawley CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Margate, Kent, UK
- Age: 5-8 weeks
- Weight at study initiation: males 135-145g, females 127 -137g.
- Fasting period before study: yes

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 ml/kg at a concentration of 10mg/ml in arachis oil
- Amount of vehicle (if gavage):10mg/m

Doses:

2000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:The rats were observed for clinical signs of toxicity and mortality at 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the observation period. Body weights were recorded prior to dosing on day 0 and then at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No clinical signs of systemic toxicity were noted.

Gross pathology:

Gross pathology was unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Octadecanol (CAS 112-925) (Tradename: Kalcol 8098 ) is > 2000 mg/kg.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Octadenol (CAS 112-92-5) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 1 studies according to OECD TG 401 in Wistar and in Sprague-Dawley CD rats.

The study in Sprague-Dawley CD rats is reported here.

In this study 5 male and 5 female fasted Sprague-Dawley CD rats were dosed by oral gavage with 1-Octadenol (Tradename Kalcol 8098) at a single dose level of 2000 mg/kg based on a range finding test. The test item was administered as a 10mg/mLsolution in arachis oil in a volume of 200 mL/kg.

The rats were observed for clinical signs of toxicity and mortality at 30 minutes, 1, 2 and 4 hours after dosing and thereafter daily throughout the observation period. Body weights were recorded prior to dosing on day 0 and then at 7 and 14 days. All animals were subject to pathological examination at the end of the observation period.

There were no deaths. No clinical signs of systemic toxicity were noted. All animals showed the expected body weight gain over the observation period. Pathological examination was unremarkable.

The rat oral LD50 for Kalcol 8098 is >2000 mg/kg.

(Reference: Hempstock, C. 1996b. Kalcol 8098: Acute oral toxicity (limit test) in the rat. SPL Project Number 140/501)

Reference 7

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1981

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

OTHER SPECIFICS: Tadename Lorol/Lanette 18

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Hanover, Germany
- Weight at study initiation: average body weight males 177g, females 141g.
- Fasting period before study: yes

Route of administration:

oral: gavage

Vehicle:

DMSO

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50% suspension in DMSO
- Amount of vehicle (if gavage):10 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the observation period

Clinical signs:

other: Directly after application the animals showed moderate piloerection and slight sedation. These effects vanished completely within 24 hours.

Gross pathology:

Round deposits of test substance remained in the stomach. There were no other gross pathological observations.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Octadecanol (CAS 112-92-5) (Tradename:Lorol/Lanette 18 ) is > 5000 mg/kg.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Octadenol (CAS 112-92-5) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 1 studies according to OECD TG 401 in Wistar and in Sprague-Dawley CD rats.

The study in Wistar rats is reported here.

In this study 5 male and 5 female fasted Wistar rats were dosed by oral gavage with Lorol/Lanette 18 (CAS 112 -92 -5) at a concentration of 10 mL/kg as a 50% suspension in DMSO in a single dose level of 5000 mg/kg. The rats were observed for clinical signs of toxicity and mortality.

Body weights were recorded prior to dosing. All animals were subject to gross pathological examination at the end of the observation. Directly after application the animals showed moderate piloerection and slight sedation. Group body weights increased over the 14 days observation period..

The rat oral LD50 for Lorol/Lanette 18 is > 5000 mg/kg. Signs of intoxication were confined to transient mild sedation and moderate piloerection.

(Reference: Henkel KGaA. 1981g. Octadecanol: Evaluation of acute oral toxicity. Unpublished data, Report No. R 9500191 and summary dated 1999)

Reference 8

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Remarks:

Guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

OTHER SPECIFICS: Tradename Nacol 20

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchtierzucht, Hagemann GmbH, Extertal,Germany
- Age at study initiation: 42-50 days
- Weight at study initiation:156-168 g
- Fasting period before study: yes

Route of administration:

oral: gavage

Vehicle:

other:

Remarks:

0.8% hydroxypropyl-methylcellulose gel

Doses:

8250 and 10000 mg/kg

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, food and water consumption .

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

All animals survived the 14 day observation period.

Clinical signs:

other: No clinical signs was observed.

Gross pathology:

Gross pathology was unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for 1-Eicosanol (tradename Nacol 20) is >10000 mg/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored.
The category of the long chained aliphatic alcohols (linear and essentially linear) is of a low order of acute toxicity upon oral administration.

Executive summary:

The IUCLID dataset of 1-Eicosanol (CAS 629-96-9; Tradename Nacol 20) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes 1 Klimisch 1 study according to OECD TG 401 in Sprague-Dawley rats.

In this study 10 male and 10 female fasted Sprange-Dawley rats were dosed by oral gavage with Tradename Nacol 20 in 0,8%hydroxypropyl-methylcellulose gel in two doses levels of 8250 mg/kg and 10000 mg/kg.

Mortality, food and water consumption and weight gain were monitored during the observation period from 14 days. All animals were subject to gross pathological examination.

There were no deaths. No clinical signs of systemic toxicity were noted. Pathological examination was unremarkable.

The rat oral LD50 for Nacol 20 is >10000 mg/kg.

(Reference: Laboratory of Pharmacology and Toxicology. 1987a. Acute oral toxicity of Nacol 20 in Sprague-Dawley rats)

Reference 9

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Smyth et al, 1962

GLP compliance:

no

Test type:

standard acute method

Specific details on test material used for the study:

OTHER SPECIFICS: icosanol mixed isomers

Species:

rat

Strain:

other:

Remarks:

Carworth-Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 5 weeks
- Fasting period before study: no

Route of administration:

other: not specified but presumed gavage

Vehicle:

not specified

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: no
- Other examinations performed: only mortality was examined.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 64 mL/kg bw

Based on:

test mat.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 53 760 mg/kg bw

Based on:

test mat.

Remarks:

assuming a density of the order of 0.84g/cm3

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for the mixed isomers of icosanol is > 64 mL/kg (>53760 mg/kg using the density of 0.84 g/cm3).

Executive summary:

The IUCLID dataset of 1-Eicosanol (CAS 629-96-9) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes the following Klimisch 2 study according to OECD TG 401 in Carworth-Wistar rats.

In this study 5 male non-fasted Carworth-Wistar rats were dosed orally with icosanol mixed isomers. Doses were not reporteded. Only mortality was examined. No further data were reported.

The rat oral LD50 for the mixed isomers of icosanol is > 64mL/kg (>53760 mg/kg assuming the density of 0.84 g/cm3).

(Reference:

Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C., Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Am. Ind. Hyg. Assoc. J.30(5):470-476.

Patty's Toxicology 2001 Bevan, C. Aliphatic alcohols(Monohydric alcohols) John Wiley & Sons - on line.)

Reference 10

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Principles of method if other than guideline:

no details provided

GLP compliance:

not specified

Species:

other: summary of different studies

Key result

Remarks on result:

other: The acute toxicity (LD50) of sodium sulfate has not been reliably established but is probably far in excess of 5000 mg/kg.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute toxicity (LD50) of sodium sulfate has not been reliably established but is probably far in excess of 5000 mg/kg.

Executive summary:

The acute toxicity (LD50) of sodium sulfate has not been reliably established but is probably far in excess of 5000 mg/kg.

Also human data indicate a very low acute toxicity of sodium sulfate. Human clinical experience indicates that very high oral doses of sodium sulfate, 300 mg/kg bw up to 20 grams for an adult, are well tolerated, except from (intentionally) causing severe diarrhoea. WHO/FAO did not set an ADI for sodium sulfate.

Reference 11

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: human drinking-water study

GLP compliance:

no

Species:

other: human

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ORGANISMS
- 10 Normal Human Subjects, 80% caucasian
- Age at study initiation: 24-45 years

Route of administration:

oral: drinking water

Vehicle:

water

Details on oral exposure:

DOSE VOLUME APPLIED: 36 mL/kg/d.

Doses:

Dose ranging study: 0, 400, 600, 800, 1000 and 1200 mg/L.
Single dose study: 0 and 1200 mg/L.

No. of animals per sex per dose:

Dose ranging study: 4 subjects (2 male, 2 female).
Single dose study: 6 subjects (3 male, 3 female).

Details on study design:

- Other examinations performed: clinical signs, body weight, physical examination, urinalysis, blood cell counts and serum chemistries.
During the study stool mass, frequency and consistency in mouth to anus appearance of colored markers were measured.

Statistics:

Wilcoxon signed rank test was used to compare the effects of specific concentrations of sulfate compared to distilled water.
Page's L-statistic test (trend in stool mass per hours ).

Sex:

male/female

Dose descriptor:

other: LOAEL

Effect level:

1 200 other: mg/L

Remarks on result:

other: No LD50 value defined

Clinical signs:

other: All blood and urine test results were normal. At 1200 mg/L 8 subjects rated the taste of the water as neutral-slightly unpleasant, 1 subject as moderately unpleasant and 1 subject as very unpleasant.

Other findings:

Dose ranging study:
No diarrhea during daily diaries were reported during the entire study. Mild abdominal cramps were reported by one subject for two days while receiving distilled water.
Single dose study:
Each subject showed an increase in stool mass per pool and in stool mass per hour. Stool frequencey, stool consistency, and mouth to anus appearance time were not significantly different. Two of the six subjects reported abdominal cramps, no other symptoms were recorded.

Conclusions:

When combing the results from both studies for 0 and 1200 mg/L significant decreases in stool consistency and appearance time were noted at 1200 mg/L.

Executive summary:

The IUCLID data set of Na2SO4 (CAS 7757 -82 -6) in the OECD SIDS INITIAL ASSESSMENT PROFILE of Sodium sulfate describes the following Klimisch 2 study.

Acute oral toxicity was tested in a drinking water study in 10 normal human subjects, 80% Caucasian with age between 24 -45 years.

In a range-finding study, four healthy volunteers received controlled amounts of drinking water with stepwise increasing concentrations of sulfate, up to 1200 mg/L of sulfate (0, 400, 600, 800, 1000 and 1200 mg/L), over six consecutive two-day periods. The calculated dose of sodium sulfate was 0, 21, 31.5, 42, 52,5 and 63 mg/kg/day.

Apart from a faster stool passage, no abnormalities were found.

In a subsequent two-day study, 6 volunteers received of 0 mg on the first and 63 mg sodium sulfate (1200 mg/L) on the second day. A clinically insignificant increase in stool volume, decrease in stool consistency and passage time was noted, but no change in stool frequency or diarrhea.

When combing the results from both studies for 0 and 1200mg/L significant decreases in stool consistency and appearance time were noted at 1200 mg/L.

 

Reference: Heizer, W.D., Sandler, R.S., Seal, E., Jr., Murray, S.C.,Busby, M.G., Schliebe, B.G., Pusek, S.N. (1997). Intestinal effects of sulfate on drinking water on normal human subjects. Dig. Dis.Sci. 42 (5): 1055 -1061.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Reliable, based on various studies

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: not specified

Principles of method if other than guideline:

10 male rabbits/group were treated with a slurry of 33% aqueous C12 ASO4 Na at 150, 300, 600, 1200 or 2000 mg/kg bw for 24 hours to both intact and abraded skin.

GLP compliance:

no

Specific details on test material used for the study:

OTHER SPECIFICS: 33 % slurry of the TS

Species:

rabbit

Sex:

male

Type of coverage:

not specified

Vehicle:

water

Details on dermal exposure:

TEST SITE
both to intact and abraded skin

Duration of exposure:

24 h

Doses:

single dosing with 150, 300, 600, 1200 or 2000 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 200 mg/kg bw

Based on:

act. ingr.

Mortality:

150 mg/kg bw: 1/10
300 mg/kg bw: 2/10
600 mg/kg bw: 4/10
1200 mg/kg bw: 8/10
2000 mg/kg bw: 10/10

Clinical signs:

other: tremors, tonic-clonic convulsions, respiratory failure; terminal skin appearance: slight scaling to leathery

Gross pathology:

not further specified

Mortalities were 1/10, 2/10, 4/10, 8/10 and 10/10 animals in the 150, 300, 600, 1200 or 2000 mg/kg bw groups, respectively. Clinical signs included tremors, tonic-clonic convulsions, and respiratory failure. A decrease in body weights was seen during the 14 day post-dose observation period in animals dosed with 300 or 600 mg/kg bw. At necropsy, the treated skin area appeared leathery and showed slight scaling. The LD50 was about 200 mg/kg bw, based on active ingredient.

Interpretation of results:

Category 2 based on GHS criteria

Conclusions:

The LD50 was about 200 mg/kg bw, based on active ingredient.

Executive summary:

The IUCLID dataset of C12-Alkylsulfate (CAS 151-21-3) in the OECD SIDS Initial Assessment Profile on Sodium dodecyl sulfate (SDS) describes the following Klimisch 2 study.

The acute dermal toxicity of Sodium dodecyl sulfate (CAS 151-21-3) was evaluated in male rabbits. Sodium dodecyl sulfate was applied as a 33% slurry in water at doses of 150, 300, 600, 1200 or 2000 mg/kg bw both to intact and abraded skin over 24 hrs. Clinical signs and mortality and body weights were observed during 14 days. Necropsy was performed on all animals (death and surviving) and gross pathological changes were noted.

Mortality was observed in 1/10, 2/10, 4/10, 8/10 and 10/10 animals at doses of 150, 300, 600, 1200 and 2000 mg/kg bw respectively.

The observed clinical signs include: tremors, tonic-clonic convulsions, respiratory failure, decrease in body weights (300 or 600 mg/kg bw). The terminal skin appearance was slight scaling to leathery. Necropsy data were not specified.

The male dermal LD50 of Sodium dodecyl sulfate was ca. 200 mg/kg bw based on active substance.

 

Reference: Carson S & Oser BL (1964) Dermal toxicity of sodium lauryl sulfate. J Soc Cosmet Chem 15, 137 – 147.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Contact laboratory protocol

GLP compliance:

no

Specific details on test material used for the study:

OTHER SPECIFICS: Tradename Alfol 14

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2,3 kg - 2,9 kg

Type of coverage:

other: occlusive (intact and abraded)

Vehicle:

other: 1% w/w gum tragacanth

Details on dermal exposure:

TEST SITE
- Area of exposure: the dose was applied to the trunk of the animals under occlusion.
- Type of wrap if used: plastic binder

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess material was washed away and the area dried with absorbent paper towels.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): maximum dose 3-4 mL/kg
- Concentration (if solution): 50% in 1% w/w gum tragacanth


VEHICLE
- Concentration (if solution):1%

Duration of exposure:

24 h

Doses:

2000, 4000 and 8000 mg/kg

No. of animals per sex per dose:

2 (1M+1F each intact and abraded)

Control animals:

no

Details on study design:

- Time after start of exposure: 24 h
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Mortality and clinical signs of systemic toxicity and skin reactions at application site were recorded on the day of dosing and throughout the 14 day observation period.
. Body weights were recorded prior to dosing and on observation day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: skin reactions at application site

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 8 000 mg/kg bw

Mortality:

On observation days 9 and 11.
Number of deaths at each dose: abraded 0/2, 0/2 and 2/2; intact 0/2, 0/2, 0/2.

Clinical signs:

other: At 8000 mg/kg, two surviving animals showed signs of weakness, emaciation and pallor. All returned to normal within 4 days of exposure. At 24 hours after administration all animals showed slight to moderate erythema, desquamation, wrinkling and dryness. I

Gross pathology:

Animals which succumbed showed depleted visceral fatty tissue (1 rabbit), moderate dermal irritation, and desquamation at the treatment site (2 rabbits). One animal, which was sacrificed, showed a slight accumulation of clear, viscous fluid within the peritoneal cavity and crazing over the kidney cortex. In all other animals the necropsy findings were unremarkable.

Interpretation of results:

GHS criteria not met

Conclusions:

The rabbit dermal LD50 after 24 h occlusive exposure for Alfol 14 was approximately 8000 mg/kg.
All survivors showed skin irritation at the application site throughout the observation period. Signs of intoxication included weakness, emaciation and pallor.

Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, Tradename Alfol 14) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 studies.

The study according to contract laboratory protocol, reported by Scientific Associates Inc. (1977b) in New Zealand White rabbits is reported here.

The test material Alfol 14, diluted 50% in a 1% w/w gum tragacanth was applied to the trunk of male and female rabbits for 24 h occlusive exposure at doses of 2000, 4000 and 8000 mg/kg bw. Each dose group consisted of 4 animals: 1 male and 1 female each with intact and abraded skin.

Mortality, clinical signs of systemic toxicity and skin reactions at the application site were recorded on the day of dosing and throughout the 14 day observation period. Body weights were recorded prior to dosing and on observation day 14. All decedents and survivors were subject to gross necropsy.

Mortality was observed on observation days 9 and 11.The number of deaths at each dose were: abraded 0/2, 0/2 and 2/2; intact 0/2, 0/2, 0/2.

At 24 hours after administration all animals showed slight to moderate erythema, desquamation, wrinkling and dryness. In all surviving animals desquamation and wrinkling persisted to the end of the observation period.

At 8000 mg/kg, two surviving animals showed signs of weakness, emaciation and pallor. All returned to normal within 4 days of exposure. Body weights of surviving animals showed a slight loss in 1 animal, constant weight in 1 animal and gains within expected limits in 8 animals.

Animals which succumbed showed depleted visceral fatty tissue (1 rabbit), moderate dermal irritation, and desquamation at the treatment site (2 rabbits). One animal, which was sacrificed, showed a slight accumulation of clear, viscous fluid within the peritoneal cavity and crazing over the kidney cortex. In all other animals the necropsy findings were unremarkable.

The rabbit dermal LD50 for Alfol 14 (24 hours occluded) was approximately 8000 mg/kg bw.

(Reference: Scientific Associates, Inc. 1977b Hayes Consultancy Service Bromley, Kent).

Reference 3

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1969

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Smyth et al, 1962

GLP compliance:

no

Specific details on test material used for the study:

OTHER SPECIFICS: Test substance: tetradecanol (mixed isomers)

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 -3.5 kg

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: entire trunk

Duration of exposure:

Not reported

Doses:

Not reported

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Sex:

male

Dose descriptor:

LD50

Effect level:

7.13 mL/kg bw

95% CL:

4.41 - 11.52

Remarks on result:

other: Equivalent to 5847 mg/kg using the density of 0.82 g/cm3.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was 7.13 mL/kg (confidence limits 4.41-11.52 mL/kg)., equivalent to 5847 mg/kg using the density of 0.82 g/cm3. Results were not reported in detail.

Executive summary:

The IUCLID dataset of 1-Tetradecanol (CAS 112-72-1, tetradecanol (mixed isomers)) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes two Klimisch 2 acute dermal toxicity studies.

The study according to the method of Smyth et al, 1962 , reported by Smith et al. (1969) in New Zealand White rabbits is reported here. 

Tetradecanol (mixed isomers) was applied on the entire trunk of male New Zealand White rabbits under occlusion.

The rabbit dermal LD50 for tetradecanol (mixed isomers) was 7.13 mL/kg (confidence limits 4.41-11.52 mL/kg), equivalent to 5847 mg/kg using the density of 0.82 g/cm3.

(Reference: Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C., Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Am. Ind. Hyg. Assoc. J. 30(5):470-476).

Reference 4

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1962

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Qualifier:

according to guideline

Guideline:

other: Smyth et al, 1962

GLP compliance:

no

Specific details on test material used for the study:

OTHER SPECIFICS: Test substance: icosanol (mixed isomers)

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 2.5 -3.5 kg

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: entire trunk

No. of animals per sex per dose:

4

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs

Sex:

male

Dose descriptor:

LD50

Effect level:

> 20 mL/kg bw

Remarks on result:

other: >16800 mg/kg using the density of 0.84 g/cm3.

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 was >20 mL/kg (>16800 mg/kg using the density of 0.84 g/cm3). Results were not reported in detail.

Executive summary:

The IUCLID dataset of 1 -Eicosanol (CAS 629 -96 -9, icosanol (mixed isomers)) in the OECD SIDS Initial Assessment Profile Long Chain Alcohols describes one Klimisch 2 study according to the method of Smyth et al., 1962 in New Zealand White rabbits. 

Undiluted icosanol (mixed isomers) was applied on the entire trunk of male rabbits under occlusion. Clinical signs were recorded during a 14 day observation period.

The rabbit dermal LD50 for icosanol (mixed isomers) was >20 mL/kg (>16800 mg/kg using the density of 0.84 g/cm3).

(Reference: Smyth, H.F., Carpenter, C.P., Weil, C.S., Pozzani, U.C.,Striegel, J.A., and Nycum, J.S. 1969. Range-finding toxicity data: List VII. Hyg. Assoc. J.30(5):470-476.)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Reliable, based on various studies

Additional information

No extra testing was performed as literature data were available as weight-of-evidence studies for the various components of the registered substance. A selection of most reliable sources (Klimisch 1-2) was made.

Acute oral toxicity:

Various literature data were available in rats for the long chain alcohols (LCHO) with chain length between C14 and C20, as summarised below.

-      The rat oral LD50 for LCOH 14 (Alfol 14; 1-Tetradecanol;CAS 112-72-1) was >20000 mg/kg (SIDS, 2006; Scientific Associates, Inc. 1977b) and 26980 mg/kg bw (SIDS, 2006; Smyth et al, 1969; Patty, 2001; Opdycke, 1975).

-      The rat oral LD50 for LCOH 16 (1-Hexadecanol; CAS 36653-82-4) was >2000 mg/kg (SIDS, 2006; Hempstock, 1996a) and >5000 mg/kg bw (SIDS, 2006; Henkel 1981).

-      The rat oral LD50 for LCOH 18 (1-Octadecanol; CAS 112-925) was >2000 mg/kg (SIDS, 2006; Hempstock, 1996b) and >5000 mg/kg bw (SIDS, 2006; Henkel 1981g).

-      The rat oral LD50 for LCOH 20 (1-Eicosanol (CAS 629-96-9) was >10000 mg/kg (SIDS, 2006; LPT, 1987a) and > 53760 mg/kg bw (SIDS, 2006; Smyth et al, 1969).

For the alkyl sulfates (AS), there were no data for the C14-C20 chain lengths, however literature data were available for the C12 chain length:

-      The rat oral LD50 of C12-Alkylsulfate (CAS 151-21-3) was 1200 mg/kg on average or 1427 mg/kg bw for males and 977 mg/kg bw for females (SIDS, 2007; Henkel 1983a).

For the sodium sulfate, literature data were available:

-      The acute oral LD50 of sodium sulfate (CAS 7757-82-6) has not been reliably established but was probably >5000 mg/kg (SIDS, 2005).

-      An acute toxicity study with sodium sulfate (CAS 7757-82-6) was also available in humans tested by drink water at 0, 400, 600, 800, 1000 and 1200 mg/L (SIDS, 2005; Heizer et al., 1997). Decreases in stool consistency were noted at 1200 mg/L as the only finding.

-      Conclusion:

When the LD50 of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on individual LD50 values, this resulted in a dermal LD50 of 4654 mg/kg bw in rats. It can therefore be concluded that the oral LD50 of the registered substance is >2000 mg/kg bw. No classification is warranted.

Acute inhalation toxicity:

Acute inhalation toxicity testing is waived based on the low vapour pressure of the registered substance (4.1 Pa at 20°C).

Acute dermal toxicity:

Various literature data were available in rabbits for the long chain alcohols (LCHO) with chain length between C14 and C20, as summarised below.

·        The rabbit dermal LD50 for LCOH 14 (Alfol 14; 1-Tetradecanol;CAS 112-72-1) was approximately 8000 mg/kg (SIDS, 2006; Scientific Associates, Inc. 1977) and 5847 mg/kg bw (SIDS, 2006; Smyth et al, 1969).

-      The rabbit dermal LD50 for LCOH 20 (1-Eicosanol (CAS 629-96-9) was >16800 mg/kg (SIDS, 2006; Smyth et al, 1969).

For the alkyl sulfates (AS), there were no data for the C14-C20 chain lengths, however literature data were available for the C12 chain length:

-      The rabbit dermal LD50 of C12-Alkylsulfate (CAS 151-21-3) was 200 mg/kg bw for (SIDS, 2007; Carson & Oser, 1964).

For the sodium sulfate, no literature data were available.

Conclusion:

When the LD50 of the target substance was calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on worst case LD50 values, this resulted in a dermal LD50 of 2373 mg/kg bw in rats. It can therefore be concluded that the oral LD50 of the registered substance is >2000 mg/kg bw. No classification is warranted.

Justification for classification or non-classification

Based on these results and according to CLP (No. 1272/2008 of 16 December 2008), the registered substance does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity.