4-isopropylcyclohexanol

Endpoint summary

Description of key information

The primary irritation test (IFF, 1984) and the contact-sensitizing test (RIFM, 1975) both indicate no irritation. Therefore the substance is not classified for skin irritation under GHS guidance.

 

The primary irritation test (IFF, 1984) indicates eye irritation. The substance is classified for eye irritation under GHS guidance. Not fully reversible within 7 days, hence classified as Cat.2A.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

April 1975

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

documentation insufficient for assessment

Qualifier:

equivalent or similar to guideline

Guideline:

other: Human Maximization Test

GLP compliance:

no

Species:

other: Humans

Type of coverage:

other: Closed patch test

Preparation of test site:

not specified

Amount / concentration applied:

5% Folrosia in aqueous sodium lauryl sulfate

Duration of treatment / exposure:

48h

Observation period:

48hr, 72hr

Number of animals:

25 human subjects completed the study.

Details on study design:

Human patch test.

Irritation parameter:

other: Observation of contact-sensitization

Basis:

mean

Time point:

other: 48hr/72hr

Score:

0

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Executive summary:

There were no instances of contact-sensitization from Folrosia on the Maximization Test and no incidences of skin irritation.

Therefore it is concluded that it is unlikely that Folrosia would present a danger of contact-sensitizastion in normal, intended use.

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

30 August, 1983 - 02 September, 1983

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Well described short report. Dose, number of animals (with details), experimental design and observation period are described in the study. Performed in compliance with the FDA's GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Pine Acres Rabbitry, W. Brattleboro, VT
- Age at study initiation: 11 to 15 weeks
- Weight at study initiation: 2.5 to 3.0 kg
- Housing: No data
- Diet: Agway Prolab Rabbit formula, lot # W1 32189
- Water: no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
No data

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated site on the left side of each animal

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Dermal reactions were scored 1, 24, 48 and 72 hours after patch removal

Number of animals:

6 males

Details on study design:

TEST SITE
Approximately 24 hours prior to treatment, the fur on the sides of each animal was closely clipped with care taken not to abrade the skin. The test substance was introduced under a 1"x1" gauze pad previously secured to the test site with surgical tape. Four pads were employed, each one for a separate sample. Two different test substance pads were placed on the left side, and two more different test sample pads were placed on the right side. A 1"x1" gauze pad was applied to an untreated site on the left side of each animal to serve as control. The animals were then wrapped with an impervious covering (plastic wrap) and then stockinette to prevent removal of the patches by the animal.

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM:
The irritation was assessed according to the numerical scoring system according to OECD 404.

Irritation parameter:

erythema score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Remarks:

animal #1, #2, #3, #4, #5 and #6

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No erythema or edema was observed.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

In an acute dermal irritation study with male rabbits performed equivalent to OECD 404 guideline and GLP principles, no erythema or edema was observed.

Executive summary:

Folrosia, sample 83 -223 -02, was tested in an acute dermal irritation study with male rabbits, performed equivalent to OECD 404 guideline and GLP principles. No erythema or edema was observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Qualifier:

no guideline available

Principles of method if other than guideline:

In vivo eye irritation method. Dose selections made according to the EPA Health Effect Test Guideline.

GLP compliance:

yes

Species:

rabbit

Strain:

other: Albino New Zealand White

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

21 days

Observation period (in vivo):

21 days

Number of animals or in vitro replicates:

6

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1hr

Score:

35.9

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

25.5

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

48 h

Score:

26.1

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

72 h

Score:

36

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

19.2

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Score:

2

Max. score:

110

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

21 d

Score:

14

Max. score:

110

Interpretation of results:

Category 2A (irritating to eyes) based on GHS criteria

Conclusions:

Not fully reversible within 7 days, hence classified as Cat.2A.

Executive summary:

Based on the results of this study, Folrosia is classified as moderately irritating to the Rabbit Eye.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)