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

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Justification for type of information:

See attached read-across justification

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

read-across source

Reference

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.)

Cross-reference 2

Reason / purpose for cross-reference:

read-across source

Reference

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

 

Cross-reference 3

Reason / purpose for cross-reference:

read-across source

Reference

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)

Cross-reference 4

Reason / purpose for cross-reference:

read-across source

Reference

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)

Cross-reference 5

Reason / purpose for cross-reference:

read-across source

Reference

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)

Cross-reference 6

Reason / purpose for cross-reference:

read-across source

Reference

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)

Cross-reference 7

Reason / purpose for cross-reference:

read-across source

Reference

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)

Cross-reference 8

Reason / purpose for cross-reference:

read-across source

Reference

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.)

Cross-reference 9

Reason / purpose for cross-reference:

read-across source

Reference

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.

Cross-reference 10

Reason / purpose for cross-reference:

read-across source

Reference

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.

Cross-reference 11

Reason / purpose for cross-reference:

read-across source

Reference

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.

Materials and methods

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

944-399-8

Cas Number:

not yet assigned

Molecular formula:

see information in structural formula

IUPAC Name:

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: calculated by concentration addition based on the general equation as presented in the CLP regulation on mixtures (2008), based on individual LD50 values

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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 an oral 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.

Executive summary:

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 an oral 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.