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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:
1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study methodology followed was equivalent or similar to OECD TG 404 and there is no mention in the report on the status of compliance with the Principles of Good Laboratory Practice (GLP).
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:
1989
Report Date:
1989

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:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): n-propyl propionate
- Physical state: colorless, transparent, low viscosity liquid
- Analytical purity: 100%
- Lot/batch No.: 51-535; 52-19 (15RLRX51)
- Storage condition of test material: room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: assumed to be in-house
- Age at study initiation: young adults
- Weight at study initiation: 2.0 - 3.0 kg
- Fasting period before study: no
- Housing: assumed to be individually housed
- Diet: appropriate commercial diet, ad libitum
- Water: municipal water, ad libitum

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact, clipped skin
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4-hours
Observation period:
one hour, one day, 2 days, 3 days and 7 days
Number of animals:
3 males + 3 females
Details on study design:
The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and is loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
of 6 animals
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritation parameter:
edema score
Remarks:
of 6 animals
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Irritant / corrosive response data:
A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days.
Other effects:
none

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 and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for skin irritation
Executive summary:

In this study, three male and three female New Zealand White rabbits were dermally dosed with 0.5 ml of undiluted n-propyl propionate. The dose was applied to the clipped, intact skin of 6 rabbits under a gauze patch and was loosely covered with impervious sheeting and the animals restrained for the 4-hour contact period. Excess sample was removed after contact period. Skin reaction was scored, by the method of Draize, at one hour, one day, 2 days, 3 days and 7 days.

A 4-hour application of 0.5 ml of n-propyl propionate to occluded rabbit skin resulted in no erythema, edema or other irritation on any of 6 rabbits. The dose sites remained unaffected through 7 days. Under the conditions of the study and based on the Guidance to Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of substances and mixtures, n-propyl propionate will not be classified for skin irritation.