Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The results were well documented. However, indications on environmental conditions are missing. No guideline was followed and the study was not GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No precision was indicated in the study report concerning the guideline followed
GLP compliance:
no
Remarks:
Study performed before GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): triisopropyl phosphite
- Batch: 03102

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: abraded and not abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5mL of undiluted test material
Duration of treatment / exposure:
72h
Observation period:
24h and 72h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: back and flanks (4 sites exposure)
- % coverage:
- Type of wrap if used: plastic wrapping patches (2 inches sqare)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24h

SCORING SYSTEM: Draize &Al for edema and erythema

Results and discussion

In vivo

Irritant / corrosive response data:
Primary irritation score : 3.8

Any other information on results incl. tables

Primary skin irritation test – Albinos Rabbits

Animal number

Irritation scores for abraded skin site at

Irritation scores for abraded skin site at

24 hours

 

72 hours

 

24 hours

 

72 hours

 

Erythema

Edema

Erythema

Edema

Erythema

Edema

Erythema

Edema

1

3

2

3

1

3

2

3

1

2

2

2

2

1

2

2

2

1

3

3

2

3

1

2

2

2

1

4

2

2

2

0

3

2

2

0

5

3

2

3

1

2

2

2

0

6

2

2

2

1

2

2

2

1

Mean

2.5

2.0

2.5

0.8

2.3

2.0

2.2

0.7

Subtotal

7.8

7.2

 

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information
Conclusions:
The substance is judged moderately irritating.
Executive summary:

Based on an overal score of primary skin irritation of 3.8, the test material is judged moderately irritating.