Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent to OECD TG 402 and the report contains suffficient information to permit a meaningful evaluation of study results
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:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): UCAR N-pentyl propionate
- Molecular weight: 144.2
- Physical state: clear colourless, low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: BRRC Sample No. 51-19
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in-house
- Age at study initiation: adults
- Weight at study initiation: 2.0-3.0 kg
- Housing: group housed
- Diet (e.g. ad libitum): appropriate commercial diet, ad libitum
- Water (e.g. ad libitum): municipal water, ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
New Zealand White rabbits were subjected to 24 hours of contact with the test material retained under impervious sheeting on the clipped, intact skin of the trunk. For larger doses, gauze was wrapped around the trunk over the sample to prevent leakage. Vetrap bandaging tape was wrapped over the impervious sheeting and the animal returned to its cage for the contact period. After the contact period, excess fluid was removed to prevent accidental ingestion.
Duration of exposure:
assumed to be 1 hour
Doses:
16 ml/kg
No. of animals per sex per dose:
5 male + 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for skin reactions and body weights - 1 hour, 7 days and 14 days
- Necropsy of survivors performed: yes
Statistics:
LD50 and the estimated LD50 slopes are estimated by the moving average method

Results and discussion

Preliminary study:
not applicable
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)
Mortality:
None
Clinical signs:
None noted in males while in females one animal appeared emaciated with distended abdomen and diarrhoea.
Body weight:
All animals appeared to gain weight at 14 days
Gross pathology:
No gross pathological changes attributable to exposure were noted
Other findings:
not applicable

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:
Under the conditions of the study, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.
Executive summary:

In this dermal study, a group of 5 male and 5 female New Zealand rabbits (adults, weighing between 2.0 -3.0 kg) were exposed to 16 ml/kg of UCAR n-pentyl propionate under occlusive conditions and observed for 14 days for mortality and signs of toxicity. There were no mortalities noted and clinical signs of toxicity were limited to 1 female animal which appeared to be emaciated with distended abdomen and diarrhoea. Under the conditions of the study, the dermal LD50 of the UCAR n-pentyl propionate to New Zealand White rabbits was greater than 16 ml/kg (equivalent to 13920 mg/kg) and would not be classified as per Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.