A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducting according to OECD method by a GLP accredited laboratory.

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

Adopted 24 February 1987

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

EC Number:

412-450-9

EC Name:

A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Cas Number:

131766-73-9

Molecular formula:

C11H20O3

IUPAC Name:

reaction mass of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

The mean inital body weights were 238 g for males and 219 g for females.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test material was applied undiluted and occluded to a skin area about 50 x 50 mm.

Duration of exposure:

24 hour exposure

Doses:

2.0 g/kg

No. of animals per sex per dose:

5/sex

Control animals:

not specified

Details on study design:

Five clipped CD (Sprague-Dawley origin)Crl:CD BR VAF plus rats per sex were used. The mean inital body weights were 238 g for males and 219 g for females. Test material was applied undiluted and occluded to a skin area about 50 x 50 mm. At the end of the 24 hour exposure the application site was washed. The observation period was 14 days. The observations were survival, signs, body weight and necropsy.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths following a single dermal dose.

Clinical signs:

other: No signs of systemic reaction to treatment. At sites of application, no irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals).

Gross pathology:

Terminal autopsy revealed no macroscopic abnormalities.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose to rats of tetrahydro-4-methyl-2-propyl-2H-pyran-4-yl acetate was found to be greater than 2.0 g/kg bodyweight.

Executive summary:

Test material was applied at a dose of 2,000 mg/kg bw undiluted and occluded to a skin area about 50 x 50 mm of 5 male and 5 female Sprague-Dawley origin rats according to OECD method 402. No signs of systemic reaction to treatment, dermal changes, abnormal bodyweight gains or macroscopic abnormalities were observed. The acute lethal dermal dose to rats of the test substance was found to be greater than 2.0 g/kg bodyweight.