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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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 according to OECD TG 404 and the report contains sufficient 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 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified

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
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

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped intact skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml undiluted UCAR n-pentyl propionate
Duration of treatment / exposure:
4 hours
Observation period:
one hour, 1 day, 2 days, 3 days and 7 days
Number of animals:
3 male + 3 female rabbits
Details on study design:
New Zealand White rabbits were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Remarks:
over 6 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
No signs of erythema and edema were noted in any of the exposed animals
Other effects:
One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related

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, UCAR n-pentyl propionate would not be be classified as a skin irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures
Executive summary:

In this study, the skin irritation potential of undiluted UCAR n-pentyl propionate was evaluated on three male and three female New Zealand White rabbits over a 4 hour contact period. The animals were dosed topically with 0.5 ml of UCAR n-pentyl propionate to the clipped intact skin of the trunk under a gauze patch and loosely covered with impervious sheeting. The animals were restrained for the 4-hour contact period. Excess samples were removed after the contact period and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days and 7 days with perios extended upto 14 days depending on the skin recations noted. No signs of erythema and edema were noted in any of the exposed animals. One female rabbit was found dead on day 7 with no apparent signs of irritation, concluded to be not treatment related. Under the conditions of the study, UCAR n-pentyl propionate would not be be classified as a skin irritant according to the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures.