Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From December 9 to 24, 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP study conducted similarly to OECD Guideline 402 with minor deviations: no data about purity and no certificate of analysis of the test substance; no data on humidity and temperature, female animals bodyweight < 200 g at study initiation
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
no data about purity and no certificate of analysis of the test substance; no data on humidity and temperature; female animals bodyweight at study initiation < 200 g
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Name of test material : (2E)-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol / 2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol
Molecular formula : C14H24O1
Smiles notation: OCC(=CCC(C(C(=C1)C)(C)C)C1)CC

Test animals

Species:
rat
Strain:
other: Tac:N(SD)fBR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Inc., Germantown, USA
- Age at study initiation: 6 weeks
- Weight at study initiation: Males: 249-291 g; females: 167-191 g
- Housing: Individually housed in stainless steel cages with wire mesh floors and automatic watering devices
- Diet (e.g. ad libitum): Purina Lab Chow, ad libitum
- Water (e.g. ad libitum): Filtered tap water, ad libitum
- Acclimation period: 13 days

ENVIRONMENTAL CONDITIONS
- Air changes: 14/hour
- Photoperiod: 12 hours dark / 12 hours light

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Intrascapular region
- % coverage: 30% of the body surface
- Type of wrap if used: Test sites were not wrapped; appropriate test substance was applied by syringe and gentle inunction to the clipped area and allowed to remain in contact with the skin and open air

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Test sites were not wiped after 24 hours because no excess test article was present.
Duration of exposure:
24 hours
Doses:
5 mL/kg bw
No. of animals per sex per dose:
Five
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Animals were observed frequently for mortality, morbidity and overt toxic signs for the first 5 hours after dosing and twice daily thereafter for 14 days. Body weights were obtained on Days 0 and 14.
- Necropsy of survivors performed: Yes; surviving animals were sacrificed and examined grossly
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 mL/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
- Clinical signs included lacrimation, diarrhea, crusty material on eyes and nose, desquamation, urine soaked fur, aggressiveness, vocalisation when touched, sore on back, and red appearance of the skin.
- No important differences in the incidence and/or nature of clinical signs between sexes were found.
Body weight:
All animals showed expected gain in bodyweight.
Gross pathology:
Findings at gross necropsy were few (yellow rectangular firm area (lobes adhered) on liver of one male) and did not reveal any test material-related trends.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the acute dermal LD50 of the test item was higher than 5 mL/kg bw therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.
Executive summary:
In an acute dermal toxicity study performed similarly to OECD guideline 402 in compliance with GLP, a group of Tac:N(SD)fBR rats (5/sex) received a single dermal dose of the test item at 5 mL/kg on clipped area of intrascapular region representing 30% of the total body surface area. The application was allowed to remain in contact with the skin and open air for 24 hours. Parameters evaluated included survival, clinical observations, bodyweight gain and necropsy findings in all animals after a 14 days observation period. No mortality was observed. All animals showed expected gain in bodyweight. Clinical signs included lacrimation, diarrhea, crusty material on eyes and nose, desquamation, urine soaked fur, aggressiveness, vocalisation when touched, sore on back, and red appearance of the skin. No important differences in the incidence and/or nature of clinical signs between sexes were found. Findings at gross necropsy were few (yellow rectangular firm area (lobes adhered) on liver of one male) and did not reveal any test material-related trends. The acute dermal LD50 was higher than 5 mL/kg bw therefore it is not classified according to Directive 67/548/EEC and CLP Regulation (EC) n° 1272/2008.