4-tert-butylcyclohexyl acetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Old study (pre-OECD and pre-GLP) but comparable to OECD test guideline No. 402 with deviations: only 3 rabbits per sex were used.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

only 3 animals/sex; environmental conditions not reported

Principles of method if other than guideline:

Protocol #DLD (11/7/78) supplied by IFF and dated 12 October 1978

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

trans-4-tert-butylcyclohexyl acetate

EC Number:

217-598-6

EC Name:

trans-4-tert-butylcyclohexyl acetate

Cas Number:

1900-69-2

Molecular formula:

C12H22O2

IUPAC Name:

trans-4-tert-butylcyclohexyl acetate

Constituent 2

Reference substance name:

cis-4-tert-butylcyclohexyl acetate

EC Number:

233-881-7

EC Name:

cis-4-tert-butylcyclohexyl acetate

Cas Number:

10411-92-4

Molecular formula:

C12H22O2

IUPAC Name:

cis-4-tert-butylcyclohexyl acetate

Test material form:

liquid

Details on test material:

- Description: clear liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: C.S.E. colony located in Brancheville, N.J.
- Age at study initiation: young adult
- Weight at study initiation: 2.45-3.50 kg
- Housing: singly
- Diet (e.g. ad libitum): Purina Rabbit Chow
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Standard laboratory conditions

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: shaved skin on the back
- % coverage: approximately 20 %
- Type of wrap if used: plastic sleeves ('Baggies')

REMOVAL OF TEST SUBSTANCE
- Washing (if done): disposable napkin moistened with saline
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5 mL/kg bw

Rabbits were placed in restrainers for the 24 hour period following application.

Duration of exposure:

24 hours

Doses:

5 mL/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (signs of toxicity and death): twice daily (once daily on Saturday and Sunday)
- Frequency of observations and weighing: on the day of dosing and before necropsy
- Necropsy of survivors performed: yes

Statistics:

none

Results and discussion

Preliminary study:

not applicable

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Based on:

test mat.

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 mL/kg bw

Based on:

test mat.

Mortality:

No animal died during the study

Clinical signs:

other: Slight to moderate erythema was observed during the first 24 hours after application. All rabbits exhibited a slight scaliness over the treated area, which was first observed on Day 8 and persisted to the end of the study.

Gross pathology:

Agonal subcapsular haemorrhage observed in the right or left kidney in 2 rabbits. Pale liver in 1 rabbit.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50Combined > 5 mL/kg bw (> 4680 mg/kg bw)
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a limit acute dermal toxicity study performed before but similarly to the OECD guideline No. 402, groups of young adult albino New Zealand rabbits (3/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 5 mL/kg bw (ca. 4680mg/kg bw; density = 0.936). The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

 

No mortality occurred during the study and no clinical signs were observed. There was no adverse effect on bodyweight gain. Slight to moderate erythema was observed during the first 24 hours after application. All rabbits exhibited a slight scaliness over the treated area, which was first observed on Day 8 and persisted to the end of the study.

 

Dermal LD₅₀Combined > 5 mL/kg bw (> 4680 mg/kg bw)

 

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.