Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study conducted similarly to OECD Guideline 402 with deviations: purity of test item not reported; source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
purity of test item not reported; duration of exposure, source and sex of animals and environmental conditions not reported; acclimation period not reported; observation period was 3 days instead of 14 days
Principles of method if other than guideline:
Not applicable
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol
EC Number:
252-744-2
EC Name:
(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol
Cas Number:
35836-73-8
Molecular formula:
C11H18O
IUPAC Name:
(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethanol
Test material form:
liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Doses:
2500 and 5000 mg/kg bw
No. of animals per sex per dose:
2 animals at 2500 mg/kg and 8 at 5000 mg/kg
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 3 days
- Necropsy of survivors performed: Yes; gross necropsy was performed on all animals at the termination of the study.
Statistics:
None

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: One rabbit died on Day 2 and one on day 3, out of 8 animals
Mortality:
One rabbit died on Day 2 and one on Day 3
Clinical signs:
other: Slight redness at 5000 mg/kg in one rat and moderate redness and edema in others, ataxia, ptosis and piloerection were observed.
Gross pathology:
Liver mottled, lungs dark and area of exposure very red and edematous in one animal.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of Nopol is higher than 5000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.
Executive summary:

In an acute dermal toxicity study performed similarly to Guideline OECD 402, groups of rabbits (2 to 8 animals/dose) were given a single dermal application of Nopol at 2500 (2 animals) and 5000 (8 animals) mg/kg bw. Animals were observed for mortality and clinical signs for 3 days.

Slight to moderate erythema and edema were noticed throughout the observation period. Ataxia, ptosis and piloerection were observed at 5000 mg/kg bw. The dermal LD50 of the test item was considered to be higher than 5000 mg/kg bw in rabbits.

The acute dermal LD50 of Nopol is higher than 2000 mg/kg bw in rabbits therefore it is not classified according to CLP Regulation (EC) N° 1272/2008 and GHS.