Fatty alcohols, C12-18 (even numbered), manuf. of, destn. residues

Endpoint summary

Description of key information

ORAL: An acute oral toxicity study in female Sprague-Dawley rats was conducted with Alcohols, C18-22, distn. residues. This study was conducted according to OECD 425 and was GLP compliant. On the basis of this study the acute oral LD50 for alcohols, C18-22, distillation residues was reported at >2000mg/kg.bw in female rats.
This result is used in a read-across approach for alcohols, C12-18, distn. residues. 
DERMAL:  An acute dermal toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with Alcohols, C18-22, distn. residues. This study was conducted according to OECD 402 and was GLP compliant. On the basis of this study the acute dermal LD50 for Alcohols, C18-22, distn. Residues was reported at >2020mg/kg.bw in male/female rats.
This result is used in a read-across approach for alcohols, C12-18, distn. residues.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)

Deviations:

no

GLP compliance:

yes

Test type:

up-and-down procedure

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Texas Animal Specialties, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 163 - 176 g
- Fasting period before study: 16 hours
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22
- Humidity (%): 50 - 95
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2009-09-22 To: 2009-10-15

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 40 % (w/v)
- Amount of vehicle (if gavage): 5.00 mL/kg
- Justification for choice of vehicle: no justification given
- Lot/batch no. (if required): no data (Parade, Exp Apr 2010)
- Purity: no data


MAXIMUM DOSE VOLUME APPLIED: 0.88 mL

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: Observation for mortality and clinical/behavioral signs of toxicity were made three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Body weights were recorded just prior to dosing and on days 7 and 14.

Statistics:

not performed

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: One animal showed salivation, crusting around the muzzle, and polyuria on days 0 and 1. The other animals were normal at each observation point.

Gross pathology:

no observable abnormalities were seen

Other findings:

none

Table: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity(#/total)
	Male	Female	Combined		Male	Female	Combined
2000	not tested	0/5	0/5	-	not tested	1/5	1/5

 

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 was estimated to be greater than 2000 mg/kg bw in female albino rats.

Executive summary:

The test substance, Alcohols, C18 -22, distn. residues (CAS No.: 1160164 -88-4), was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose at a level of 2000 mg/kg. The study was terminated following the stopping rules of this procedure. No mortality occurred during the study. Clinical signs included salivation, crusting on muzzle, and polyuria in one animal, which were no longer evident by day 2. There was no effect on body weight gain in animals. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg.

This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP guideline study for alcohols, C18-22, distn. residues. Used in a read-across approach for alcohols, C12-18, distn. residues.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP guideline study. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

relative humidity was outside protocol range, but did not affect study outcome

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Texas Animal Specialities, Humble, TX, USA
- Age at study initiation: 8 weeks
- Weight at study initiation: 273 - 312 g (males); 187 - 202 g (females)
- Housing: 1 animal per cage in suspended, wire-bottomed, stainless steel cages
- Diet (e.g. ad libitum): PMI Feeds Inc. Formulab #5008, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 50 - 94
- Air changes (per hr): 10 - 12
- Photoperiod (hrs dark / hrs light): 12 / 12


IN-LIFE DATES: From: 2009-09-24 To: 2009-10-08

Type of coverage:

semiocclusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: dorsal surface of the trunk
- % coverage: 10
- Type of wrap if used: The area of application was covered with a 2 x 4 in. surgical gauze patch and secured with non-irritation adhesive tape. The trunk of each animal was then wrapped with vet wrap that was secured in place with non-irritation adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with room temperature tap water and a clean cloth to remove as much residual test substance as possible
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2020 mg/kg bw
- Constant volume used: no, an individual dose was calculated for each animal based on its day 0 body weight just before exposure
- For solids, paste formed: no


VEHICLE
- Concentration: 1.0 mL/g test substance
- Purity: deionized water

Duration of exposure:

24 hours

Doses:

2020 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: Observations for mortality and clinical/behavioral signs of toxicity were made at least three times on the day of dosing (day 0) and at least once daily thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Individual body weights were recorded just prior to dosing and on days 7 and 14. Observations for evidence of dermal irritation were made at approx. 60 minutes after removal of wrappings and on days 4, 7, 11 and 14.

Statistics:

not performed

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 020 mg/kg bw

Mortality:

no mortality occurred

Clinical signs:

other: no clinical signs of toxicity or dermal irritation were recorded

Gross pathology:

no observable abnormalities were detected

Other findings:

none

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute dermal LD50 was greater than 2020 mg/kg bodyweight in male and female rats.

Executive summary:

The test substance, Alcohols, C18 - 22, distn. Residues (CAS No. 1160164 -88 -4), was evaluated for its dermal toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mL of deionized water/g test substance, at a level of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There was no effect on body weight gain with the exception of two animals that lost weight during the 1st week. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg.

This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Quality of whole database:

GLP guideline study for alcohols, C18-22, distn. residues. Used in a read-across approach for alcohols, C12-18, distn. residues.

Additional information

ORAL: In a GLP compliant OECD 425 (up and down procedure) the acute oral toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed in female albino rats. No mortality occurred during the study. Clinical signs included salivation, crusting on muzzle, and polyuria in one animal, which were no longer evident by day 2. There was no effect on body weight gain in animals. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was estimated to be greater than 2000 mg/kg. This result is used in a read-across approach for alcohols, C12-18, distn. residues.

 

DERMAL: In a reliable GLP compliant OECD 402 study, the test substance, alcohols, C18-22, distillation residues (CAS No. 1160164-88-4), was evaluated for its dermal toxicity potential and relative skin irritancy when a single dose moistened with 1.0 mL of deionized water/g test substance, at a level of 2020 mg/kg, was applied to the intact skin of albino rats. No mortality occurred during the study. There was no effect on body weight gain with the exception of two animals that lost weight during the 1st week. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The estimated LD50, as indicated by the data, was determined to be greater than 2020 mg/kg. This result is used in a read-across approach for alcohols, C12-18, distn. residues.

 

INHALATION: Physio-chemical properties of alcohols, C12 -18, distillation residues can be used to assess whether there is a necessity for acute inhalation toxicity testing. In this instance the substance is of low volatility with a measured vapour pressure  < 5 Pa at 20 °C and 50 °C. Consequently acute inhalation toxicity testing for this test item is not required.

Justification for selection of acute toxicity – oral endpoint
No substances specific data are available for Alcohols, C12-18, distn. residues. Therefore, available data for the analogue substance Alcohols. C18-22, distn. residues are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 425 limit test at 2000 mg/kg bw (conducted under GLP) is available for the test substance (Alcohols. C18-22, distn. residues). During the study none of the animals died and except for one animal rats did also not show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2000 mg/kg bw).

Justification for selection of acute toxicity – dermal endpoint
No substances specific data are available for Alcohols, C12-18, distn. residues. Therefore, available data for the analogue substance Alcohols. C18-22, distn. residues are used. Details on the read-across justification are summarized in the attached read-across report.
An OECD 402 limit test at 2020 mg/kg bw (conducted under GLP) is available for the test substance (Alcohols. C18-22, distn. residues). During the study none of the animals died and none of the animals did show clinical signs. Body weight gain was normal for all animals. Gross pathology did not result in any findings. Therefore, it can be concluded that the substance is practically non-toxic (LD50 > 2020 mg/kg bw).

Justification for classification or non-classification

The results for the test substance alcohols, C18-22, distn. residues are used in the REACH registration of alcohols, C12-18, distn. residues in a read-across approach.

The test substance,alcohols, C18-22, distillation residuesis of low acute toxicity via ingestion (oral LD50 >2000mg/kg bw) or via dermal exposure (dermal LD50 >2020mg/kg bw). These findings do not warrant classification ofalcohols, C18-22, distillation residuesunder the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) do not warrant classification under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations (DSD/DPD).