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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 equivalent or similar to OECD TG 404 and the report contains sufficient information to permit a meaningful evaluation of study results
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:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Principles of method if other than guideline:
not applicable
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Butyl propionate
EC Number:
209-669-5
EC Name:
Butyl propionate
Cas Number:
590-01-2
Molecular formula:
C7H14O2
IUPAC Name:
butyl propionate
Details on test material:
- Name of test material (as cited in study report): UCAR n-butyl propionate
- Physical state: clear clolourless low viscosity liquid
- Analytical purity: 99+ %
- Impurities (identity and concentrations): < 1%
- Lot/batch No.: 51-18
- Stability under test conditions: yes
- Storage condition of test material: at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: assumed to be adults
- Weight at study initiation: no information available
- Fasting period before study: fasted overnight before dosing
- Housing: assumed to be individually housed
- Diet (e.g. ad libitum): ad libitum except during exposure
- Water (e.g. ad libitum): ad libitum except during exposure

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
Duration of treatment / exposure:
4-hour
Observation period:
7-14 days
Number of animals:
6 rabbits
Details on study design:
0.5 ml of UCAR n-butyl propionate was applied to the clipped intact skin under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Irritation parameter:
edema score
Basis:
mean
Remarks:
of 6 animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: no irritation noted
Irritant / corrosive response data:
There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate
Other effects:
One rabbit was found dead on day 7 with no evidence of this being related to the treatment.

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, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.
Executive summary:

In this study, 0.5 ml of UCAR n-butyl propionate was topically applied to the clipped intact skin (trunk) of 3 male and 3 female New Zealand White rabbits, under a gauze patch and loosely covered with impervious sheeting. Excess sample was removed after contact and skin reactions were scored by Draize method at 1 hour, 1 day, 2 days, 3 days, 7 days and 10 and 14 days after application. There were no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate. An incidental mortality unrelated to the exposure of one male rabbit on day 7 was noted.

Under the conditions of the study, no signs of erythema, edema or other irritation noted in any of the 6 animals exposed dermally to UCAR n-butyl propionate and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, UCAR n-butyl propionate will not be classified for skin irritation.