Isooctadecan-1-ol

Endpoint summary

Description of key information

In an acute oral toxicity study conducted in accordance with OECD 401, a single oral administration of 2 g/kg (bw) Prisorine 3515 Iso Stearyl Aclohol was administered to 5 male and 5 female rats. No treatment related effects or mortality was reported under the conditions of this study. The LD50 is greater than 2 g/kg (bw) in the rat.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Asingle dose of 2 g/kg (bw) administered undiluted.

No. of animals per sex per dose:

5/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: All animals were weighed prior to administration of the test substance and then on day 3,4,7 and day 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: All animals were sacrificed on day 14 and an examination of the main vital organs was conducted

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths were reported during the study period.

Gross pathology:

No evidence of toxicity and no lesions noted in any of the organs that were examined.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An LD50 value of >2000 mg/kg bw was determined in a reliable study conducted according to current OECD guideline and in compliance with GLP.

Executive summary:

In an acute oral toxicity study conducted in accordance with OECD 401, a single oral administration of 2 g/kg (bw) Prisorine 3515 Iso Stearyl Aclohol was administered to 5 male and 5 female rats. No treatment related effects or mortality was reported under the conditions of this study. The LD50 is greater than 2 g/kg (bw) in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

LD50 > 2000 mg/kg (bw)

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

6 180 mg/kg bw

Quality of whole database:

Read across from a Rel 2 dermal study (similar to OECD 402) in rabbits.,3333

Additional information

Three well conducted acute oral toxicity limit test studies (OECD 401) in rats using re-distilled Isostearyl alcohol, Alcohol Isostearlyique and Isostearyl alcohol reported no treatment related effects or mortality under the conditions of the respective studies. The LD50 is greater than 2000 mg/kg (bw) (Saboureau 1989, 1989a, 1989b).

Using read across from a well conducted acute dermal study in rats (Alcohols C14 -15, Rel 2), the LD50 was determined to be 6180 mg/kg (bw) (Lifestream Laboratories 1966).On the basis that there are studies for acute oral and dermal toxicity, and also taking into account the extremely low volatility of Isostearyl alcohol, there is no requirement for additional data to be obtained for acute inhalation toxicity.

Justification for selection of acute toxicity – oral endpoint
Good quality limit study (rel 1, GLP) conducted in accordance with OECD 401.

Justification for selection of acute toxicity – inhalation endpoint
Data waiver

Justification for selection of acute toxicity – dermal endpoint
Read across from a Rel 2 dermal study (similar to OECD 402) in rabbits.

Justification for classification or non-classification

On the basis of the results from the acute oral toxicity study in rats (Saboureau 1989) the criteria under EC Regulation No. 1272/2008 for classification under acute toxicity are not fulfilled.