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Toxicological information

Acute Toxicity: dermal

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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

Constituent 1
Chemical structure
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.

Applicant's summary and conclusion