Reaction Mass of Cyclohexanepropanol, 2,2,6-trimethyla-propyl-, (alpha.R,1R,6S)- and Cyclohexanepropanol,2,2,6-trimethyl-a-propyl-, [1a(S*),6b]- (9CI)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From June 15 to June 29, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Study comparable to OECD test guideline No. 402 with deviations not affecting the integrity of the result. Indeed, only 6 animals were tested instead of the 10 required by the OECD Test Guideline No. 402 for a limit test. However having 4 more animals would not impact the LD50 value since no mortality occurred within this study. Moreover half of the animals had abraded skin which improved skin permeability, and therefore absorption. GLP status not reported.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

other: Section 1500.4 - Federal Hazardous Substance Act Regulation - 16 CFR

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

yes

Remarks:

Limit test using 6 animals instead of 10, half of them having abraded skin

Principles of method if other than guideline:

Not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Molecular formula:

C15H30O

IUPAC Name:

(3R*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Constituent 2

Reference substance name:

(3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Molecular formula:

C15H30O

IUPAC Name:

(3S*)-1-[(1R*,6S*)-2,2,6-trimethylcyclohexyl]hexan-3-ol

Test material form:

not specified

Details on test material:

- Physical state: no data
- Sample received: 1984-06-04
- Storage condition of test material: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: no data
- Weight at study initiation: 2.3-3.0 kg bw.
- Fasting period before study: no.
- Housing: individually, in stainless steel cages with elevated wire mesh flooring.
- Diet (e.g. ad libitum): Wayne 15% Rabbit ration ad libitum.
- Water (e.g. ad libitum): tap water ad libitum.
- Acclimation period: appropriate time.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15.5 - 23
- Humidity (%): 40-45
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: backs (clipped skin, 3 with abraded skin).
- % coverage: approximately 10%.
- Type of wrap if used: large gauze patches, impervious material wrapped snugly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no (wiping only)
- Time after start of exposure: 24 hours.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 g/kg bw.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations (systemic and topical): frequently during the first day, and twice per day thereafter (morning and afternoon).
- Frequency of weighting: on the day of dosage, weekly thereafter, and prior to sacrifice.
- Necropsy of survivors performed: yes (gross necropsy)

Statistics:

None

Results and discussion

Preliminary study:

Not applicable

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed.

Clinical signs:

other: None.

Gross pathology:

No gross abnormalities were noted.

Other findings:

Mild erythema and severe oedema were observed after unwrapping at 24 hours. Eschar was noted for all animals by day 4 which was still evident at 14 days.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Dermal LD50Combined > 2000 mg/kg bw.
Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

Executive summary:

In a limit acute dermal toxicity study performed similarly to the OECD test guideline No. 402, New Zealand White rabbits (3/sex) were occlusively exposed to undiluted test material for 24 hours at dose of 2000 mg/kg bw. The animals were observed for mortality, clinical signs including dermal reactions and body weight for 14 days and then necropsied for macroscopic observations.

No mortality and no clinical signs were observed during the study. A loss of body weight was noted for 1/3 female at 7 days.

Mild erythema and severe oedema were observed after unwrapping at 24 hours. Eschar was noted for all animals by day 4 which was still evident at 14 days.

Dermal LD50Combined > 2000 mg/kg bw.

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute dermal toxicity endpoint.