Registration Dossier

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:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well conducted study performed in accordance with recognised test methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FHSA
Principles of method if other than guideline:
Method used was Draize as described in "Appraisal of the safety of chemicals in food, drugs and cosmetics" as published by the Association of Food and Drug Officials of the United States.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Diethyl phthalate
- Analytical purity: 100%
- Lot/batch No.: ARG-01-3379
- Storage condition of test material: Not reported

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation:
- Weight at study initiation:
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported

IN-LIFE DATES: From: To: Not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: Shaved and abraded sites on each rabbit
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml of DEP as supplied was applied to a 2X2 cm area of shaved and intact or abraded skin.
Duration of treatment / exposure:
The exposure period was 24 hours.
Observation period:
The observation period was 72 hours with evaluations of skin reaction performed at the end of the 24h contact period and again 48 hours later (72 h after application).
Number of animals:
3
Details on study design:
Three healthy, normal, albino rabbits were used. On the day before the study began 10% of the total body surface was carefully clipped free of hair. On the posterior of the clipped area several minor abraisions were made so as to penetrate the stratum corneum but not disturb the derma in order to prevent bleeding.
0.5 ml of DEP was applied to the unscarified area and an additional 0.5 ml was applied to the scarified area. Each 2X2 cm application area was covered with Webril patches and the entire experimental area sealed with Blenderm surgical tape.
The animals were imobilised in racks for 24 hours. At the end of this contact period and 48 hours later the treated skin was evaluated using the Draize method, as described in "Appraisal of the safety of chemicals in food, drugs and cosmetics" as published by the Association of Food and Drug Officials of the United States.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: No response on intact or abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: No response on intact or abraded skin
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: No response on intact or abraded skin
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Reversibility:
other: Not applicable
Remarks on result:
other: No response on intact or abraded skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No evidence of irritation or corrosive effects. Score of 0 throughout for all 3 rabbits
Other effects:
None reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In this study when DEP was applied as solution to the intact or abraded skin of the rabbit for 24 hours under occlusive conditions. No reaction was observed on either type of skin.
Executive summary:

Primary skin irritation has been investigated according to FHSA test methods with 24 hours exposure to intact and abraded skin. The substance was not irritating to the skin of the albino rabbit.

Exposure was for a 24 hour period in contrast with 4 hours required by current OECD/EU test methods. However, the information obtained clearly demonstrate the substance to be not irritating and classification as a skin irritant would not be required under the EU/GHS classification scheme.