cis-2-tert-butylcyclohexyl acetate

Endpoint summary

Description of key information

Skin corrosion/irritation: not corrosive or irritating (OECD TG 404)

Eye irritation: not irritating (OECD TG 405)

Respiratory irritation: Not irritating based on absence of corrosion and irritation.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

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

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

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

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

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

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.

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2 May 1977 to 12 May 1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 10 weeks old

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as a control

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.1 mL

Duration of treatment / exposure:

Single instillation

Observation period (in vivo):

4 days

Number of animals or in vitro replicates:

4

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not performed

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test substance as supplied caused no corneal, conjunctival or iridial lesions when assessed at 24 hours. One animal showed signs of discomfort when treated.

Interpretation of results:

other: Not irritating

Remarks:

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

Conclusions:

The substance is not irritating to rabbit eyes.

Executive summary:

In an eye irritation study with rabbits, similar to OECD TG 405 but non-GLP, 0.1 mL of the test substance was applied to one eye of each of 4 rabbits. Eyes were examined 24 hours after treatment and afterwards at daily intervals. The mean cornea, conjunctiva, iris and chemosis scores over 24, 48 and 72 hours were all 0. One animal showed signs of discomfort when treated. The substance is considered to be not irritating to eyes.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Corrosion: Substance is not corrosive because the substance is not a skin or eye irritant.

Skin irritation

In a skin irritation test with 7 New-Zealand rabbits, preceding OECD guidelines and 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.

Eye irritation

In an eye irritation study with rabbits, preceding OECD guidelines and GLP (Unilever Research Laboratory, 1977b), 0.1 mL of the test substance was applied to one eye of each of 4 rabbits. Eyes were examined 24 hours after treatment and afterwards at daily intervals. The mean cornea, conjunctiva, iris and chemosis scores over 24, 48 and 72 hours were all 0. One animal showed signs of discomfort when treated. The substance is considered to be not irritating to eyes.

Respiratory irritation

There are no occupational or consumer data indicating respiratory tract irritation. There are also no relevant experimental guidelines or results available that indicate respiratory irritation, therefore respiratory irritation is not anticipated. The ECHA guidance presents (R7a: 7.1.12.1) that respiratory irritation maybe be indicated when the substance is a severe irritant. The substance is not a severe skin irritant and not an eye irritant. In absence of other supporting respiration irritation information the substance is regarded a non-respiratory irritant.

Justification for classification or non-classification

Based on the available information, classification and labelling for skin, eye and respiratory irritation is not warranted in accordance with EU CLP (EC No. 1272/2008 and its updates).