Registration Dossier

Administrative data

Description of key information

No significant positive reactions were observed in the skin/eye irritation on rabbit for the test substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
Qualifier:
no guideline available
Principles of method if other than guideline:
Patch test
GLP compliance:
no
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
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
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

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

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye 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: Non GLP but in accordance with the guidelines
Qualifier:
according to
Guideline:
other: FDA guideline FEDERAL REGISTER vol. 38 n. 187, s.27019/1973
Deviations:
not specified
GLP compliance:
no
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues 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
Vehicle:
other: sesame oil
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL undiluted
Duration of treatment / exposure:
24 hs
Observation period (in vivo):
Up to 72 hs
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological solution
- Time after start of exposure: 24 hs

SCORING SYSTEM: According to FDA Classification , 1959 s.51, reported in the Table below.

TOOL USED TO ASSESS SCORE: fluorescein in dilution 0.01 %, instilled after 48 and 72 hs.
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24 h
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
The test item results not irritant to the rabbit eye.
Other effects:
None
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
The test item results not irritating to the rabbit eye.
Executive summary:

The test item was instilled into the right eye of 6 rabbits, while the left eye served as control. 0.1 mL of undiluted product was instilled in the eye and washed after 72 hs. The observation period was up to 72 hs. Fluorescein was instilled after 48 hours and 72 hours to assess the scores. The irritation index was calculated based on effects on cornea, iris and conjunctiva after 1, 7, 24, 48 and 72 hours. The maximum score was 2 and it was observed after 7 hours. The effect was fully reversible after 24 hours. Therefore, the product is classified as not irritant to eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Even if the presented studies are quite old, the whole data base is deemed to be sufficient to satisfy the data requirements for the tonnage band 100 -1000 t/a, as information on all the route of exposure are available, showing an overall low irritating potential of PCBTF to the test animals. The test species are in agreement with those indicated in the most recent test guidelines and therefore are relevant and adequate for the classification and the CSA.


Justification for selection of skin irritation / corrosion endpoint:
only one study available

Justification for selection of eye irritation endpoint:
only one study available

Justification for classification or non-classification

The substance is not classified as irritant or corrosive for skin or eye as no effects were observed during the irritation/corrosion test.