4-methyl-3-decen-5-ol

Endpoint summary

Description of key information

Key study acute dermal toxicity: No adverse effects observed, LD50 > 5000 mg/kg, Levenstein 1975 (3,7-dimethyl-4,6-octadien-3-ol)

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:

weight of evidence

Study period:

not reported

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The data is taken from an abstract of an internal company report with incomplete reporting on the method; it is not possible to assess the accuracy of the information presented.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

Principles of method if other than guideline:

Mice were exposed to 1000, 2000, 4000 or 8000 test material via the oral route. Ten mice were exposed per dose level and the rate of mortality was recorded at each.

GLP compliance:

no

Test type:

other: not reported

Limit test:

no

Species:

mouse

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: 17-22g

Route of administration:

oral: unspecified

Vehicle:

other: Gum Arabic

Doses:

1000, 2000, 4000 and 8000 mg/kg

No. of animals per sex per dose:

10 animals per dose

Control animals:

not specified

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 8 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 > 8000 g/kg

Mortality:

3/10 animals died at the highest dose administered 8000.No other mortalities were recorded.

No further information on results is available.

Interpretation of results:

not classified

Remarks:

Migrated informationCriteria used for interpretation of results: EU

Conclusions:

The LD50 of the test material was recorded to be > 8000 mg/kg in mice.

Executive summary:

In a non GLP compliant study the oral toxicity of the test material was determined by exposing mice to 100, 2000, 4000 or 8000 test via an unspecified oral route. Ten mice were exposed per dose and the rate of mortality was recorded. The LD₅₀ was determined to be > 8000 mg/kg.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Oral Toxicity

In the key study (Levenstein, 1972) the acute toxicity of the test material was determined in a limit test performed at 5000 mg/kg (5 mL/kg). The study was performed to sound scientific principles with limited but a sufficient level of reporting to assess the quality of the submitted data. The method followed was similar to the current standardised guideline OECD 402 with deviations not thought to affect the validity of the results presented. Four rabbits were exposed to the test material under an occlusive dressing for 24 hours. Animals were exposed on the back of each animal to intact and abraded. Abraded skin was prepared by making epidermal abrasions every 2 -3 cm, longitudinally, over the clipped area. Post exposure the dressing was removed, the dermal reaction scored and the site thoroughly wiped to remove any remaining test material. Animals were then returned to their cages and observations continued for 14 days. Under the conditions of the test, no mortality was observed in the limit test. All animals showed a moderate erythema after 24 hour exposure, similar reactions observed on both the intact and abraded skin.

 

Dermal Toxicity

The acute dermal toxicity of the test material has been assessed by read-across to structural, mechanistically similar substance using the OECD QSAR Toolbox to predict the dermal LD50 of 3030 mg/kg. QSAR predicting is attached within the endpoint.

Predicted LD50 in rabbits after dermal application is 3030 (1790 - 5150) mg/kg.

 

Inhalation Toxicity

In line with Column 2, point 8.5.2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral and dermal routes, which is more appropriate when considering the properties of this substance.

Justification for classification or non-classification

According to the criteria outlined in Regulation 1272/2008 and Directive 67/548/EEC, the test material does not meet the criteria for classification for acute toxicity.