[No public or meaningful name is available]

Endpoint summary

Description of key information

The substance is not classified as skin irritant according to the CLP criteria.

Based on the no rinse group, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. Based on the rinse group, the test substance is considered to be a moderate irritant to the ocular tissue of the rabbit. 

 

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:

May 31, 1999 - June 11, 1999

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

no guideline followed

Principles of method if other than guideline:

The potential of skin irritation was assessed by repeated dermal administration of dilutions for two weeks using rabbits.

GLP compliance:

yes

Specific details on test material used for the study:

Name: P-Menthane-3,8-dio1
Molecular weight: 172.27
Properties at room temperature: Colorless solid or solid solution
Stability: Stable at room temperature
Storage condition: Cool dark place

Species:

rabbit

Strain:

other: Japanese White rabbits (Kbs: JW, Healthy)

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: KITAYAMA LABES CO., LTD. (3052 Kawakita, Arai-ku, Ina-shi, Nagano, Japan)
- Age at study initiation: 10 to 11 weeks
- Weight at study initiation: 2.52 to 2.62 kg
- Housing: individually in an automatic water-washable aluminum cage (350W × 500D × 420H mm).
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 8-day quarantine/acclimation period

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 10 or more times per hour with all-flash air system
- Photoperiod (hrs dark / hrs light): 12 hours/day

Type of coverage:

open

Preparation of test site:

clipped

Amount / concentration applied:

1.0 and 10.0%

Duration of treatment / exposure:

14 days

Observation period:

daily before application and 24h after final application.

Number of animals:

6

Details on study design:

Two sites along the midline of the rabbit back that had been cleared off fur on the day before the first administration were designated as the application sites, and the four corners of each site were marked with the oil-based ink. Using a disposable syringe, each 0.5 mL of the test substance solution at various concentrations was open topically administered to corresponding application site once daily for 2 consecutive weeks.

Irritation parameter:

edema score

Basis:

mean

Time point:

14 d

Score:

0

Max. score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

10.0% concentration

Time point:

14 d

Score:

0.17

Max. score:

0.17

Reversibility:

fully reversible

Remarks on result:

other: very slight erythema

Irritation parameter:

overall irritation score

Basis:

mean

Remarks:

1.0% concentration

Time point:

14 d

Score:

0.29

Max. score:

0.33

Reversibility:

fully reversible

Remarks on result:

other: very slight erythema

Irritant / corrosive response data:

very slight erythema fully reversible

Interpretation of results:

GHS criteria not met

Conclusions:

According to the results of the study, the test substance does not meet the CLP classification criterias.
Therefore, the substance is not classified according to the CLP criteria.

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:

07/07/1997 - 16/10/1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Specific details on test material used for the study:

Clear Viscous liquid

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Age at study initiation: 11-12 weeks
- Weight at study initiation: 2.5 - 2.7kg
- Housing: individually in suspended stainless steel cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 65-78%
- Humidity (%): 38-81%
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod: 12 hrs light -12 hrs dark

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL of 100 % test substance

Duration of treatment / exposure:

once

Observation period (in vivo):

28 days

Number of animals or in vitro replicates:

9

Details on study design:

After instillation of the test article, test and control eyes of rabbits were rinsed with physiological saline. The remain rabbits were not rinsed.

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #3

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 21 days period

Irritation parameter:

chemosis score

Remarks:

No rinse group

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Observation over 28 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Observation over 21 days period

Irritation parameter:

conjunctivae score

Remarks:

No rinse group

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Observation over 28 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #6

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #5

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #4

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 21 days period

Irritation parameter:

iris score

Remarks:

No rinse group

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Observation over 28 days period

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #6

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #5

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #4

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 21 days period

Irritation parameter:

cornea opacity score

Remarks:

No rinse group

Basis:

animal #1

Time point:

24/48/72 h

Score:

3

Max. score:

4

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Remarks:

Observation over 28 days period

Irritation parameter:

chemosis score

Remarks:

Rinsed group

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 10 days period

Irritation parameter:

chemosis score

Remarks:

Rinsed group

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

chemosis score

Remarks:

Rinsed group

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

Rinsed group

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 10 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 10 days period

Irritation parameter:

conjunctivae score

Remarks:

Rinsed group

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

conjunctivae score

Remarks:

Rinsed group

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 14 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

Rinsed group

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 10 days period

Irritation parameter:

iris score

Remarks:

Rinsed group

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

iris score

Remarks:

Rinsed group

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

cornea opacity score

Remarks:

Rinsed group

Basis:

animal #3

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 10 days period

Irritation parameter:

cornea opacity score

Remarks:

Rinsed group

Basis:

animal #2

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Irritation parameter:

cornea opacity score

Remarks:

Rinsed group

Basis:

animal #1

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Remarks:

Observation over 14 days period

Other effects:

No Rinsed goup:
Noevascularization: 3/6
Corneal edema: 1/6
raised area on the cornea: 1/6

Rinsed group:
Noevascularization: 1/3

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the no rinse group, the test item is considered to be a severe irritant to the ocular tissue of the rabbit. Based on the rinse group, the test substance is considered to be a moderate irritant to the ocular tissue of the rabbit.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)