Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2000-06-05 to 2000-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 2000-06-05 to 2000-07-13

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl : CD® (SD) IGS BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males - 201 to 207 g, females - 202 to 222 g
- Housing: in suspended polypropylene cages furnished with woodflake. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: ad libitum during the study
- Water: ad libitum during the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: the back and flanks of each animal
- % coverage: 10 % of the total body surface area
- Type of wrap: surgical gauze
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers.

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.21 mL/kg

Duration of exposure:

24 hours

Doses:

2000 mg/kg

No. of animals per sex per dose:

5 male and 5 female

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 min, 1, 2 and 4 hours after dosing and sunsequesntly once daily for 14 days.
- Frequency of weighings: prior to application on day 0 and on day 7 and 14
- Necropsy of survivors performed: yes

Statistics:

No statistical analysis was performed.

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

No abnormalities were noted at necropsy.

Other findings:

- Dermal reactions: No signs of dermal irritation were noted during the study.

Interpretation of results:

GHS criteria not met

Conclusions:

The acute dermal LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Executive summary:

A study according OECD 402 (1987) and Commission Directive 92/69/EEC Method B.3 was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. A group of 10 animals (5 males and 5 females) was given a single 24-hour, semioccluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. No death animals were observed during the study. No signs of systemic toxicity or dermal irritation were noted. All animals showed an expected gain in bodyweight during the study period. No abnormalities were noted at necropsy of the surviving animals. The acute dermal LD50 of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD 402 (1987)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

EC Number:

947-711-0

Molecular formula:

C14H28O

IUPAC Name:

Reaction mass of 1-[rac-(1R,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol isomer 1 and 1-[rac-(1S,6S)-2,2,6-trimethylcyclohexyl]pentan-3-ol

Test animals

Species:

rat

Strain:

Sprague-Dawley

Remarks:

Crl : CD® (SD) IGS BR

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: males - 201 to 207 g, females - 202 to 222 g
- Housing: in suspended polypropylene cages furnished with woodflake. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet: ad libitum during the study
- Water: ad libitum during the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

- Dose volume: 2.21 mL/kg
- Dose level: 2000 mg/kg

Duration of treatment / exposure:

24 hours

Observation period:

14 days

Number of animals:

5 females and 5 males

Details on study design:

TEST SITE
- Area of exposure: the back and flanks of each animal
- % coverage: 10 % of the total body surface area
- Type of wrap: surgical gauze
- On the day before treatment the back and flanks of each animal were clipped free of hair using veterinary clippers.

REMOVAL OF TEST SUBSTANCE
- Washing: wiped with cotton wool moistened with distilled water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 2.21 mL/kg

SCORING SYSTEM:
- Method of calculation: The skin reactions were scored using a 0-4 scale (Draize) as follows: Erythema and Eschar formation: No erythema = 0, very slight erythema (barely perceptible) = 1, well-defined erythema = 2, moderate to severe erythema = 3, severe erythema (beet redness) to slight eschar formation (injuries in depth) = 4; Oedema formation - No oedema = 0, very slight oedema (barely perceptible) = 1, slight oedema (edges of area well-defined by definite raising) = 2, moderate oedema (raised approximately 1 mm) = 3, severe oedema (raised more than 1 mm and extending beyond the area of exposure) = 4.

- Duration of observation period following administration: 14 days
- Frequency of observations: at 30 min, 1, 2 and 4 hours after dosing and subsequesntly once daily for 14 days.
- Frequency of weighings: prior to application on day 0 and on day 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of dermal irritation or systemic toxicities were observed in the test animals after a single application of test material.

Other effects:

No death animals were observed during the study. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test item showed no skin irritation effects on the tested rats in the Acute Dermal Toxicity study.