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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: non GLP OECD guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
adopted 1981
Deviations:
no
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of the test substance used in the study report: Dipropoxy-p-toluidin

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking & Churchill Ltd., Huntingdon, UK
- Diet : ad libitum
- Water : ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25°C
- Humidity (%): 40-60 %

- Photoperiod (hrs dark / hrs light):12 hours light/12 hours dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 g of the test material
Duration of treatment / exposure:
4 hours
Observation period:
1 hour after application
24 hours after application
48 hours after application
72 hours after application
7 days after application
Number of animals:
3 females
Details on study design:
TEST SITE
- Area of exposure: 25 mm x 25 mm patch
- Type of wrap if used: elastic, adhesive dressing pervious to air

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
Draize Evaluation of dermal irritation (according to OECD guideline 404)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 1-3
Time point:
other: 1 h, 24 h, 48 h, 72 h, 7 days
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal: 1-3
Time point:
other: 1 h, 24 h, 48 h, 72 h, 7 days
Score:
0
Max. score:
4

Applicant's summary and conclusion

Conclusions:
After application of the test substance to the skin of rabbits no irritating effects were observed.