cis-2-tert-butylcyclohexyl acetate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not reported

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Reversibility cannot be assessed (no observations after day 3)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

cis-2-tert-butylcyclohexyl acetate

EC Number:

243-718-1

EC Name:

cis-2-tert-butylcyclohexyl acetate

Cas Number:

20298-69-5

Molecular formula:

C12H22O2

IUPAC Name:

2-tert-butylcyclohexyl acetate

Test material form:

liquid

Details on test material:

Test material used is consistent with the substance identity as described in section 1.2 of IUCLID - company composition for the quality described under the common name Verdox.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 9-12 weeks

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: cyclamen aldehyde and diethyl phthalate were used as positive controls

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.2 g

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, 48 and 72 hours post-treatment

Number of animals:

7

Details on study design:

TEST SITE
- Area of exposure: 1'' x 1''
- % coverage: 100 %
- Type of wrap if used: canvas body sleeve

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test sites were wiped clean of excess material
- Time after start of exposure: 4 hours

SCORING SYSTEM:
a: marginal/very slight = 1
b: slight = 2
c: fairly distint = 3
d: quite distinct = 4
e: becoming well developed = 6
f: well developed = 8
g: becoming severe = 10
h: severe = 12

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.7

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.05

Max. score:

4

Reversibility:

not fully reversible within: 72 hours

Irritant / corrosive response data:

When applied to rabbit skin, the test substance produced fairly distinct erythema and marginal to fairly distinct oedema, cracking and scaling. The level of response was slightly lower tha that produced by the control, cyclamen aldehyde, which produced fairly distinct to distinct erythema, slight to distinct oedema and scaling with slight tot failrly distinct cracking. The control diethyl phthalate produced only a marginal response.

Applicant's summary and conclusion

Interpretation of results:

other: Not irritating

Remarks:

in accordance with EU CLP (1272/2008 and its updates)

Conclusions:

The substance is considered to be not irritating in a rabbit covered patch skin irritation test.

Executive summary:

In the skin irritation test with 7 New-Zealand rabbits, similar to OECD TG 404 but non-GLP, mean erythema and oedema scores over 24 / 48 / 72 hours were 1.7 and 1.05. In only one out of 7 animals mean erythema score over 24, 48 and 72 hours was 2.33. When applied to rabbit skin under semi-occlusive conditions for 4 hours, the test substance produced fairly distinct erythema and marginal to fairly distinct oedema, cracking and scaling. The skin effects were not fully reversible within 72 hours, after which the observation stopped. Considering their slight severity, the dermal changes are likely to be fully reversible within 14 days. Based on the average erythema and oedema scores, the substance is considered to be not irritating to skin.