Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: not GLP but in accordance with guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Patch test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Parachlorbenzotrifluorid
- Physical state: colourless liquid

Test animals

Species:
rabbit
Strain:
Himalayan
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 1,5 -2,0 kg
- Housing: individually caged
- Diet: ERKA 8300 ad libitum
- Water: ad libitum


IN-LIFE DATES: From: 3 February To: 7 February

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: sesame oil
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL undiluted
- Amount(s) applied (volume or weight with unit): 10% diluted
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: right flank for undiluted product application, left flank for diluted product application
-Area of coverage: 2.5 x 2.5 cm
- Type of wrap if used: surgical gauze wrapped by PVC sheet and fixed by adhesive tape

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

SCORING SYSTEM: Federal Register 38, N. 187 (27/09/1973), cap. 1500.41

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
1.9
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: UNDILUTED Irritation index = Sum of irritation score at 24 + at 72 hours/ number of animals x number of scores. Irritation score = erythema score on intact skin + erythema on scarified skin + oedema on intact skin + oedema on scarified skin
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 and 72 h
Score:
0.4
Reversibility:
not fully reversible within: 72 h
Remarks on result:
other: DILUTED Irritation index = Sum of irritation score at 24 + at 72 hours/ number of animals x number of scores. Irritation score = erythema score on intact skin + erythema on scarified skin + oedema on intact skin + oedema on scarified skin
Irritant / corrosive response data:
Non irritant and non corrosive

Any other information on results incl. tables

Application on right flank (undiluted product)

Animal N.

Skin Reaction

24 hs after Application

48 hs after Application

72 hs after Application

96 hs after Application

Sum

Intact

Scarified

Intact

Scarified

Intact

Scarified

Intact

Scarified

24+72  (1+5+6)

1

Erythema  Oedema

1

2

1

1

0

1

1

0

0

0

0

0

 

 

5

2

Erythema  Oedema

1

4

1

3

1

2

1

1

1

1

1

0

 

 

12

3

Erythema  Oedema

1

3

1

3

0

2

1

2

0

2

0

2

 

 

12

4

Erythema  Oedema

0

3

0

1

0

2

0

1

0

1

0

1

 

 

6

5

Erythema  Oedema

1

2

1

1

0

1

1

0

0

1

1

0

 

 

7

12

Erythema  Oedema

0

1

0

1

0

1

0

1

0

0

0

1

 

 

3

Application on left flank (diluted product)

Animal N.

Skin Reaction

24 hs after Application

48 hs after Application

72 hs after Application

96 hs after Application

Sum

Intact

Scarified

Intact

Scarified

Intact

Scarified

Intact

Scarified

24+72  (1+5+6)

1

Erythema  Oedema

0

0

1

0

0

0

0

0

0

0

0

0

 

 

1

2

Erythema  Oedema

0

0

0

0

0

0

0

0

0

0

0

0

 

 

0

3

Erythema  Oedema

0

1

1

1

0

0

0

1

0

0

1

0

 

 

4

4

Erythema  Oedema

0

1

0

0

0

1

0

0

0

0

0

0

 

 

1

5

Erythema  Oedema

0

0

1

0

0

0

0

0

0

0

1

0

 

 

2

12

Erythema  Oedema

0

0

0

1

0

0

0

0

0

0

0

0

 

 

1

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information nor diluted nor undiluted Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The test item results non irritating and non corrosive to skin.
Executive summary:

The test item was applied to the skin of the flank of 6 rabbits, through occlusive coverage. The right flank was treated with the undiluted product, while the left flank was treated with the 10% dilution of the product in sesame oil. The exposure time was 24 hours; the observation period was up to 72 hs. The irritation index was calculated based on erythema and oedema scores after 24 and 72 hours and it was found to be 1.9 for the undiluted product and 0.4 for the dilution. It is concluded that the test item is not irritating nor corrosive to skin.