Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study similar to OECD Guideline No 402 with deviations: no data about purity and no test substance certificate of analysis ; no data on age, gender and source of animals; no data on housing and environmental conditions; observation period: 7 days instead of 14; performed on abraded skin
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:
1972
Report Date:
1972

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 test substance; no data on age, gender and source of animals; no data on housing and environmental conditions; observation period: 7 days; performed on abraded skin
Principles of method if other than guideline:
not applicable
GLP compliance:
no
Remarks:
pre-dating GLP regulation
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name of the test item (as cited in the study report): NOPYL ACETATE
Source: Research Institute for Fragrance Materials, Inc., USA
Label: 71-10-57
Colour: clear
Date received: 21 January 1972

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
Weight at study initiation: 1.9-2.4 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
Area of exposure: clipped abraded abdominal skin
Type of wrap if used: wrapped with binders of rubber dam, gauze and adhesive tape
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 rabbits
Control animals:
not specified
Details on study design:
Mortality and toxic effects were observed for a period of 7 days.

Necropsy of survivors performed: Yes
Other examinations performed: dermal reactions: erythema, edema and atonia
Statistics:
no data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no mortality
Clinical signs:
No evidence of toxicity; all animals appeared normal at the end of the study.
Body weight:
Normal gain in bodyweight.
Gross pathology:
No abnormalities were noted at necropsy.
Other findings:
Dermal reactions:
- slight erythema in 8, 4 and 1 animal on Days 1, 2 and 3, respectively; moderate erythema in 1 animal on Day 1
- slight edema in 8 and 4 animals on Days 1 and 2, respectively; moderate edema in 1 animal on Day 1
- complete recovery within 4 days
- no signs of atonia were observed during the study

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of nopyl acetate is greater than 2000 mg/kg bw in rabbits therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and CLP Regulation (EC) No 1272/2008.
Executive summary:

In an acute dermal toxicity study (limit test), a group of 10 New Zealand White rabbits were administered a single dermal dose of nopyl acetate at 2000 mg/kg bw on clipped abraded abdominal skin using an occlusive patch for 24 h. Animals were then observed for mortality, clinical signs, bodyweights and dermal reactions for 7 days and were all macroscopically necropsied after sacrifice.

 

No deaths occurred throughout the study. Normal body weight gain was observed in all animals. At necropsy, macroscopic examination of main organs showed no abnormalities. Adverse dermal reactions noted were slight to moderate erythema and edema, which completely recovered to normal within four days. The acute dermal LD50 was therefore greater than 2000 mg/kg bw under test conditions.

 

The acute dermal LD50 of nopyl acetate is greater than 2000 mg/kg bw in rabbits. Therefore it is not classified for acute dermal toxicity according to Directive 67/548/EEC and according to CLP Regulation (EC) No 1272/2008.