[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

1999

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol

Molecular formula:

not applicable

IUPAC Name:

Reaction Mass of (1S,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol and (1R,2R,5R)-2-(2-hydroxypropan-2-yl)-5-methylcyclohexan-1-ol

Test material form:

liquid

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

Test animals

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

Test system

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.

Results and discussion

In vivo

Results

Results 1

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

Results 2

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

Results 3

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

Applicant's summary and conclusion

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.