Icosan-1-ol

Endpoint summary

Description of key information

The key study for acute oral toxicity, conducted according to OECD TG 401, and in compliance with GLP, reports an LD50 value of >10000mg/kg in rat (Laboratory of Pharmacology and Toxicology, 1987; rel 1). The key study for acute dermal toxicity, conducted according to generally acceptable scientific principles, reports an LD50 value of 16800 mg/kg derived from an exposure to mixed isomers of icosanol (Smyth 1969; rel 2). As no data was available for the inhalation endpoint further studies were not found scientifically justified since high reliability data was in place via the oral and dermal route. Furthermore, the weight of evidence across category suggests that the LC50 value would be higher than substantially saturated vapour.

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

Study period:

1987

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

other: 0.8% hydroxypropyl-methylcellulose gel

Doses:

8250 and 10000 mg/kg

No. of animals per sex per dose:

10

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

MORTALITY: All animals survived the 14 day observation period.

CLINICAL SIGNS: No clinical signs of toxicity. There was no adverse  effect on food intake or bodyweight gain.

NECROPSY FINDINGS: Unremarkable.

POTENTIAL TARGET ORGANS: None identified.

SEX-SPECIFIC DIFFERENCES: None

Interpretation of results:

GHS criteria not met

Conclusions:

The rat oral LD50 for Nacol 22 RD is >10g/kg. At this dose level there was no evidence of toxicity in any of the parameters monitored.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

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:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Principles of method if other than guideline:

Method: other: Smyth et al, 1962

GLP compliance:

not specified

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Vehicle:

unchanged (no vehicle)

Sex:

male

Dose descriptor:

LD50

Effect level:

7.13 mL/kg bw

Based on:

test mat.

Results were not reported in detail. The LC50 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, reported in chapter 2.3. No other details available.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

16 800 mg/kg bw

Additional information

The key acute oral study was the most recent and available study, which was conducted according to OECD TG 401, and in compliance with GLP. The study reports an LD50 value of >10000 mg/kg bw.

8250 and 10000 mg/kg bw of icosan-1 -ol in 0.8% hydroxypropyl-methylcellulose gel

were administered orally to 5 male and 5 female rats using a stomach tube. Body weight changes and clinical signs of toxicity were noted regularly. Necropsy was performed at the end of the 14 -day study period.

No mortality was observed within the 14-day study period. There were no clinical signs of toxicity and no change in body weight gain. At necropsy, no macroscopic abnormalities were observed.

The key acute dermal study was the most recent and available study, which was conducted according to generally acceptable scientifical principles. The study reports an LD50 value of 16800 mg/kg bw. The test material was applied onto rabbit skin and kept for 4 hours under occlusive dressing. The study lacks full details on materials and methods, as well as results.

Discussion of trends in the Category of C6-24 linear and essentially-linear aliphatic alcohols:

Acute toxicity tests of the linear and essentially linear alcohols do not indicate any potential hazard for acute, dermal or inhalation toxicity. Tests on various substances included in this category are all supportive of these results and do not warrant classification for most of the acute toxicity endpoints under GHS criteria. The majority of the substances are therefore not classified for acute toxicity in accordance with Regulation (EC) No 1272/2008. The only exception to this is hexan-1-ol, which finds that the acute dermal data for the test substance are consistent with Acute dermal tox category 4 and Acute oral tox 4 H302/R22, in line with the Annex VI entry.

Justification for classification or non-classification

Based on the available information, no classification required for the acute toxicity endpoints for icosan-1-ol according to Regulation (EC) No 1272/2008.