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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
(no data on positive control substance or historical controls and lack of data on test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
no data on positive control substance, lack on test substance
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
no data on positive control substance, lack on test substance
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
A non-LLNA test is available that was performed prior to the current data requirements, stipulated in Regulation (EC) No 1907/2006. In accordance with the same Regulation, the data was included to avoid unnecessary testing.

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright white
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Interfauna, Tuttlingen, Germany (main study) and Winkelmann, Borchen, Germany (pre-study)
- Weight at study initiation: 261.1 - 348.9 g
- Housing: 2 - 3 animals were housed in Makrolon IV cages.
- Diet: Altromin 3032 DK, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 50 - 60
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin perliquid DAB 8 (1. induction and challenge) and vaseline (2. and 3. induction)
Concentration / amount:
Induction: 50%
Challenge: 50%
Rechallenge: 25%
Challenge
Route:
epicutaneous, occlusive
Vehicle:
other: paraffin perliquid DAB 8 (1. induction and challenge) and vaseline (2. and 3. induction)
Concentration / amount:
Induction: 50%
Challenge: 50%
Rechallenge: 25%
No. of animals per dose:
19 (controls), 20 (in test group)
Details on study design:
RANGE FINDING TESTS:
To find an appropriate concentration for induction phase, three guinea pigs were treated on their shaved flanks for 6 h with 5, 10, 15, 30, 40 and 50% of the test substance in paraffin perliquid DAB 8. At the reading time point 24 h thereafter, no skin irritation was observed at any concentration level. To achieve a mild irritation in the induction phase, the animals were pre-treated with 10% sodium dodecylsulfate (SDS) in vaseline 24 h before the induction with 50% of the test substance.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 h
- Test groups: 0.2 mL test substance in paraffin perliquid DAB 8 (1. induction) or vaseline (2. and 3. induction); 24 h before each induction exposure, all test animals were pre-treated with 10% SDS in vaseline
- Control group: 0.2 mL paraffin perliquid DAB 8 (1. induction) or vaseline (2. and 3. induction); 24 h before induction exposure 1 and 2, the control animals 11-20 were pre-treated with 10% SDS in vaseline; 24 h before induction exposure 3, the control animals 1-10 were pre-treated with 10% SDS in vaseline
- Site: upper right flank
- Frequency of applications: every 7 days for 3 weeks
- Duration: Days 0-70-14
-Concentrations: 50%

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 28
- Exposure period: 6 h
- Test groups: 0.1 mL test substance in paraffin perliquid DAB 8
- Control group: 0.1 mL test substance in paraffin perliquid DAB 8
- Site: lower left and right flank
- Concentrations: 50%
- Evaluation (hr after challenge): 24 and 48 h

B. RECHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: 35
- Exposure period: 6 h
- Test groups: 0.1 mL test substance in paraffin perliquid DAB 8
- Control group: 0.1 mL test substance in paraffin perliquid DAB 8
- Site: upper left flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 h
Challenge controls:
The control group is actually a challenge control.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
3
Total no. in group:
19
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
10
Total no. in group:
19
Key result
Reading:
rechallenge
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
5
Total no. in group:
20
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
19
Key result
Reading:
rechallenge
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
20
Group:
positive control
Remarks on result:
not measured/tested

Any other information on results incl. tables

Table 1: Results of the challenge treatment with 50% of the test substance

animal

skin sensitisation (left flank)

test substance group

negative control group

Erythema

Edema

Erythema

Edema

24 h

48 h

24 h

48 h

24 h

48 h

24 h

48 h

guinea pig 1

0

0

0

0

0

0

0

0

guinea pig 2

0

0

0

0

0

0

0

0

guinea pig 3

0

0

0

0

0

0

0

0

guinea pig 4

0

0

0

0

0

0

0

0

guinea pig 5

1

0

0

0

0

0

0

0

guinea pig 6

0

0

0

0

0

0

0

0

guinea pig 7

0

0

0

0

0

0

0

0

guinea pig 8

1

0

0

0

1

0

0

0

guinea pig 9

0

0

0

0

0

0

0

0

guinea pig 10

1

0

0

0

guinea pig 11

1

0

0

0

0

0

0

0

guinea pig 12

0

0

0

0

0

0

0

0

guinea pig 13

0

0

0

0

0

0

0

0

guinea pig 14

0

0

0

0

0

0

0

0

guinea pig 15

0

0

0

0

0

0

0

0

guinea pig 16

0

0

0

0

1

0

0

0

guinea pig 17

0

0

0

0

1

0

0

0

guinea pig 18

0

0

0

0

0

0

0

0

guinea pig 19

0

0

0

0

0

0

0

0

guinea pig 20

1

0

0

0

0

0

0

0

Table 2: Results of the rechallenge treatment with 25% of the test substance

animal

skin sensitisation (left flank)

test substance group

negative control group

Erythema

Edema

Erythema

Edema

24 h

48 h

24 h

48 h

24 h

48 h

24 h

48 h

guinea pig 1

0

0

1

0

0

0

0

0

guinea pig 2

0

0

0

0

0

0

0

0

guinea pig 3

0

0

0

0

0

0

0

0

guinea pig 4

0

0

0

0

1

0

1

0

guinea pig 5

1

0

0

0

0

0

0

0

guinea pig 6

1

0

0

0

0

0

0

0

guinea pig 7

0

0

0

0

0

0

0

0

guinea pig 8

1

0

0

0

0

0

0

0

guinea pig 9

0

0

0

0

1

0

0

0

guinea pig 10

0

0

0

0

guinea pig 11

1

0

0

0

1

0

1

0

guinea pig 12

0

0

0

0

1

0

0

0

guinea pig 13

0

0

0

0

0

0

1

0

guinea pig 14

0

0

0

0

0

0

0

0

guinea pig 15

0

0

0

0

1

0

1

0

guinea pig 16

0

0

0

0

1

0

0

0

guinea pig 17

0

0

0

0

1

0

0

0

guinea pig 18

0

0

0

0

1

0

1

0

guinea pig 19

0

0

0

0

1

0

1

0

guinea pig 20

0

0

0

0

0

0

0

0

Very slight skin reactions were seen at the first reading in test and control animals and were reversible in all animals within 48 h. These reactions are probably caused by an irritating effect of the test substance.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008