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Administrative data

Description of key information

OECD 429, not skin sensitizer

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: read across from analogue substance
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study has been presented to ECHA in the framework of a NONS notification. The document is now public because presented more than 12 years ago. The summary received is from migrated NONS dossier
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA method not available at the time of testing
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 232 g mean weight
- Housing: 5/cage
- Diet (ad libitum): Altromin 3112
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 50 ± 20 %
- Air changes (per hr): -
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 25.10.1988 To: 18.11.1988
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
1% / 4 * 0.1 mL
Day(s)/duration:
Day 1 / single injections
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
25 % / 0.5 mL
Day(s)/duration:
Day 9 for 48 h
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
25% / 0.5 mL
Day(s)/duration:
Day 22 for 24 h
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Number of animals in challenge control group: 5
Challenge controls:
5 animals, challenge treatment on Day 14 for 24 h
Positive control substance(s):
yes
Remarks:
bi-annual test for validity of test system
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.83; 0/5 acanthosis; 3/5 mononuclear infiltration grade 1
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
25%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
25%
No. with + reactions:
1
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.73; 8/10 acanthosis grade 1; 5/10 mononuclear infiltration grade 1, 1/10 mononuclear infiltration grade 2
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
mean skin thickness: 0.73; 0/10 acanthosis; 0/10 mononuclear infiltration

After the challenge treatment, two out of 20 animals from the treatment group exhibited a slightly greater infiltration of the corium compared with the control animals.

Since any skin reaction which may have been present could not be determined visually due to the colour of the test substance itself, the evaluation was performed by means of measurement of the skin thickness.

Interpretation of results:
other: not classified under Regulation 1272/2008
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The substance was tested for skin sensitisation following EU Method B6 (GPMT). Under the experimental conditions the substance does not show any skin sensitizing properties.
Executive summary:

The substance was tested for skin sensitisation following EU Method B6 (GPMT). Under the experimental conditions the substance does not show any skin sensitizing properties.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

The analogue substace was tested for sensitising properties following EU Method B6, GPMT (NONS dossier, 1988).

Guinea Pig were topycally and intradermally induced and then challenged at a concentration of the intradermal at 1% of the test substance. Under the experimental conditions at the 25% dose the results at challenge time is 10% of skin positive reactions.

Based on the read across considerations the same resutls apply to the test item

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

A substance is classified as skin sensitizer cat 2 for Guine Pig Maximisation test

when >0.1 to <1% intradermal induction the positive skin reactions are>30 to <60% or

                             at >1% intradermal, the positive skin reactions are >30%

Based on the results of the GPMT the substance is not classified as skin sensitizer.