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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988-03-08 to 1988-03-22
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:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
(1S,2S)-1-methyl-4-(propan-2-yl)-7-oxabicyclo[2.2.1]heptan-2-ol
Cas Number:
87172-89-2
IUPAC Name:
(1S,2S)-1-methyl-4-(propan-2-yl)-7-oxabicyclo[2.2.1]heptan-2-ol
Test material form:
solid
Specific details on test material used for the study:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test substance was stored in the dark at ambient temperature.

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rats were received from a commercial supplier (Charles River U.K. Ltd.)
- Age at study initiation: 9-11 weeks
- Housing: On arrival the rats were housed in single sex groups of up to 12 to a cage; each cage measured 56 cm x 38 cm x 18 cm. The animals were quarantined in non-barriered animal rooms with access restricted to essential personnel. Prior to experimentation the animals were rehoused (as single sex group of four) in cages with stainless-steel wire-mesh floors and tops; each cage measured 38 cm x 25 cm x 18 cm. Paper-lined trays for excreta were places beneath each cage.
- Diet: PRD, labsure Animal Foods; ad libitum
- Water: Public water supply; ad libitum
wire

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal
- % coverage: 60% of the dorsal hair were shorn with electric clippers and the gauze pad with the required amount of test material was applied to the shorn skin
- Type of wrap if used: The gauze pad was held in place with adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: The skin washed with warm dilute detergent solution and dried.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The test material was administered as a powder with 0.1 mL water.

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL water
Duration of exposure:
24 h
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
No treatment related changes in behavior and demeanour were observed during the 14 day observation period.
Body weight:
All rats had gained weight relative to their day 1 bodyweights by the end of the study.
Gross pathology:
At necropsy no treatment releated macroscopic changes were recorded.

Any other information on results incl. tables

The only unusual finding recorded was the presence of liquid contents in the stomach of one male rat. This was not considered to be related to treatment.

Applicant's summary and conclusion