3-Cyclohexene-1-methanol, α,4-dimethyl-α-(4-methyl-3-penten-1-yl)-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Some deviations from the current OECD 402 and not GLP, purity and batch no. not given, but still very detailed and overall acceptable data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

active ingredient not tested up to limit dose

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol

EC Number:

208-205-9

EC Name:

(R*,R*)-α,4-dimethyl-α-(4-methyl-3-pentenyl)cyclohex-3-ene-1-methanol

Cas Number:

515-69-5

Molecular formula:

C15H26O

IUPAC Name:

6-methyl-2-(4-methylcyclohex-3-en-1-yl)hept-5-en-2-ol

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Details on test material:

Bisabolol preparation

Test animals

Species:

rat

Strain:

other: BOR:WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Winkelmann, Versuchstierzucht, 4791 Borchen 1, Gartenstraße 300
- Weight at study initiation: male: 200 - 233 g. female: 144 - 185 g
- Housing: Collection caging (Macrolon type III/max. 5 rats)
- Diet: Ssniff-R Alleindiät
- Water: ad libitum
- Acclimation period: About 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21 +/- 2 ° C
- Humidity: 45 - 55 %
- Photoperiod: 12 hours daily, from 7.00 a.m. - 7.00 p.m.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 8 x 5 cm
- Type of wrap if used: wrappings of plastic material for 24 hours


REMOVAL OF TEST SUBSTANCE
- Washing: The substance was removed with wet disposable gauze.
- Time after start of exposure: 24 h


TEST MATERIAL
- Amount(s) applied: 2.3 - 3.5 g (depending to body weight; 15 g/kg bw)

Duration of exposure:

24 h

Doses:

15 g/kg bw

No. of animals per sex per dose:

5 (scarificed skin) 5 (intact skin)

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations: 2 h, 4 h, 24 h, 48 h, 72 h, 7 and 14 days; skin alterations: 24 h, 3, 7 and 14 days; body weight: at day 0 and at day 14 (terminal necropsy)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

Pairs of two female rats (scarified) were employed in a preliminary range finding study. The dosage administrations were 15 and 5 g/kg of body weight. This preliminary study showed no mortalities.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 750 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on the information given in the report ie. > 15000 mg/kg bw 5% Dragosanostol in Vaseline

Mortality:

No mortalities were observed.

Clinical signs:

In the tested dosage the sample did not induce any clinical-toxicological symptoms.

Body weight:

Body weight changes after the observation period showed a normal weight gain.

Gross pathology:

Necropsies performed on all animals at termination exhibited no gross pathological findings.

Other findings:

- Other observations: No skin alterations were observed.