Isopropylcyclohexane

Endpoint summary

Description of key information

Isopropylcyclohexane showed slight irritant effect on the skin of male and female rabbits under conditions of the conducted study (Hüls, 1983). Furthermore isopropylcyclohexane showed no irritant effect on the eyes and mucosa of male and female rabbits in the available study (Hüls, 1983).

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:

1983-02-22 to 1983-03-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

In deviation from OECD TG 404 occlusive dressing was used.

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

occlusive dressing

GLP compliance:

no

Species:

rabbit

Strain:

other: Small white Russian, Chbb-SPF

Details on test animals or test system and environmental conditions:

- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.4-2.9 kg Environmental conditions:
- Room temperature: 20°C (+/- 1°C);
- Humidity: 60% (+/- 5%);
- Air change: 15 times/hour;
- Light: 12 hour light/dark rhythm;
- Feed: K4 complete feed for rabbits (Ssniff, Soest, Germany);
- Water: tap water ad libitum

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.5 ml undiluted test item

Duration of treatment / exposure:

4 hour(s)

Observation period:

- Post exposure observation period: 17 days
- Observations at 1, 24, 48, 72 hours, 6, 8 and 17 days after administration of the test substance

Number of animals:

3 males, 3 females

Details on study design:

- Area of exposure: 6 cm2
- Occlusion: mull patch, polyethylene film, elastic dressing for 4 hours
- Removal of test substance: washing with warm water
- Scoring system: according to Draize

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1; 24; 48; 72 h

Score:

1.29

Max. score:

8

Reversibility:

fully reversible within: 17 days

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

1.38

Max. score:

4

Reversibility:

fully reversible within: 17 days

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24; 48; 72 h

Score:

0.17

Max. score:

4

Reversibility:

fully reversible within: 48 hours

Irritant / corrosive response data:

AVERAGE SCORE
- Erythema: 1.38
- Edema: 0.17
- Irritation index: 1.29/8

Other effects:

no further information

no further information

Conclusions:

According to the study, the test item showed slight irritant effect on the skin of male and female rabbits.

Executive summary:

The aim of this study was to examine the test item for acute skin irritation in rabbits (Patch-test) .

To test the acute skin irritant effect the test item was applied to the shaven dorsal skin of 3 male and 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

The treated rabbits showed induration and dryness (day 6) of treated skin,  formation (days 8) and  subsequent detachment of  eschar until day 17.

According to the study, the test item isopropylcyclohexane showed slight irritant effect on the skin of male and female rabbits.

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:

1983-03-01 to 1983-03-04

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

no

Species:

rabbit

Strain:

other: Small white Russian

Details on test animals or tissues and environmental conditions:

TEST ANIMALS: 
- Strain: Small white Russian, Chbb-SPF
- Sex: male and female
- Source: Dr. Karl Thomae GmbH, Biberach (Germany)
- Weight at study initiation: 2.4-2.7 kg
- Number of animals: 3 per sex
- Water: ad libitum, tab water
- Diet: K4 Diet (Ssniff, Soest); ad libitum
- Controls: untreated eye
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1 °C
- Humidity (%): 60 % +/-5 %
- Air changes (per hr): 15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/light

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye

Amount / concentration applied:

ADMINISTRATION/EXPOSURE 
- Vehicle: none,
- Unchanged test item
- Amount applied: 0.05 g undiluted

Duration of treatment / exposure:

72 hour(s)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6
3 male and 3 female rabbits

Details on study design:

Comment: eyes not rinsed
EXAMINATIONS
- Ophtalmoscopic examination: 1, 24, 48, and 72 hours after treatment
- Scoring system: Draize

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

0.5

Max. score:

110

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

3

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48, 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

AVERAGE SCORE
- Cornea:  x = 0.0
- Iris:    x = 0
- Conjunctivae (Redness):   x = 0.0
- Conjunctivae (Chemosis):  x = 0.0
- Overall irritation score: 0.5/110

Other effects:

no other effects described

no further remarks

Conclusions:

Under the conditions of this study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.

Executive summary:

To test the acute irritant effect on eyes and mucosa the test item was administered undiluted into eyes or eyelid sacs of 3 male and female rabbits. Four of six rabbits showed slight redness and exsudation only one hour after administration.

Under the conditions of this study, the test item showed no irritant effect on the eyes and mucosa of male and female rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Isopropylcyclohexane was examined for acute skin irritation in rabbits (Patch-test). The test item was applied to the shaven dorsal skin of 3 male and 3 female rabbits. The product was administered undiluted and the time of exposure in the patch test was 4 hours.

The treated rabbits showed induration and dryness (day 6) of treated skin,  formation (days 8) and  subsequent detachment of  eschar until day 17. The irritation effects were fully reversible within 17 days.

According to the study, the test item isopropylcyclohexane showed slight irritant effect on the skin of male and female rabbit.

Isopropylcyclohexane was administered undiluted into eyes or eyelid sacs of 3 male and female rabbits. Four of six rabbits showed slight redness and exsudation only one hour after administration.Under the conditions of this study, the test item isopropylcyclohexane showed no irritant effect on the eyes and mucosa of male and female rabbits.

Justification for selection of skin irritation / corrosion endpoint:
Only one study available. The study is a guideline study with Klimisch score 2 (reliable with restriction).

Justification for selection of eye irritation endpoint:
Only one study available. The study is a guideline study with Klimisch score 2 (reliable with restriction).

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies in rabbits and according to the EC Regulation 1272/2008 and subsequent regulations on classification, labelling and packaging of substances and mixtures, isopropylcyclohexane does not require to be classified as a substance that is irritating for skin and/or eyes.