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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DEHP
- Name: Vestinol AH
- Purity: >99%
- Physical state: clear liquid
- Batch n°: 963
- Storage: in refrigerator, in dark, protected from air and humidity

Test animals

Species:
rabbit
Strain:
other: Little White Russian
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.1-2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum K4 diet for rabbits, Ssniff Spzialdiät GmbH, 4770 Soest
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1
- Humidity (%): 60+/-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
other: clipped (10x10cm)
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 h
Observation period:
8 d
Number of animals:
3 males
Details on study design:
The exposed skin area is 6 cm2.
After the 4-hour exposure, the exposed area was rinsed with warm water.
The skin reactions were evaluated after 1, 24, 48, and 72 hours, and after 6 and 8 days, using the grading system of the OECD guideline.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8d
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 8d
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8d
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 24, 48, 72h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
At the 1-hour observation, all rabbits showed very slight erythema, and one rabbit also a very slight oedema. At 24 hours, the reaction of one rabbit had progressed to a well-defined erythema.
At 48 hours, all rabbits had very slight erythema which at 72 hours was accompanied by a dry appearance of the skin.
At 6 days, the skin surface appeared scaly, and at 8 days the skin was free from reaction.

Any other information on results incl. tables

Animal Number Sex 1h 24h 48 h 72 h 6 days 8 days
Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema Erythema Oedema
1 38219 M 1 1 1 0 1 0 dryness 0 scaly 0 0
2 38335 M 1 0 2 1 1 0 dryness 0 scaly 0 0
3 38599 M 1 0 1 1 1 0 dryness 0 scaly 0 0

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information not classified Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Conclusions:
DEHP was slightly irritating to the skin
Executive summary:

In a study performed in accordance with OECD guideline 404, skin irritation of DEHP (> 99% pure) was studied. The hair was clipped from the dorsal and lateral part of the trunk of three male Little White Russian rabbits. The undiluted test substance (0.5 cm2) was applied to a skin area of 6 cm2 and covered with a patch. After 4 hours, the patch was removed and the skin gently rinsed with warm water. The skin reactions were evaluated after 1, 24, 48, and 72 hours, and after 6 and 8 days, using the grading system of the OECD guideline. At the 1-hour observation, all rabbits showed very slight erythema, and one rabbit also a very slight oedema. At 24 hours, the reaction of one rabbit had progressed to a well-defined erythema. At 48 hours, all rabbits had very slight erythema which at 72 hours was accompanied by a dry appearance of the skin. At 6 days, the skin surface appeared scaly, and at 8 days the skin was free from reaction. It was concluded that DEHP was slightly irritating to the skin.

Mean scores calculated for times 24, 48 and 72h of animals 1, 2 and 3 were 1, 1.33 and 1 for erythema and 0, 0.33 and 0.33 for oedema, respectively.