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Diss Factsheets

Administrative data

Description of key information

The test substance has been tested in a skin sensitization study (Guinea pig maximization according to the Magnusson & Kligman) to assess the sensitising potential.

It induced an allergic reaction in 10/20 (1streading) and 11/20 animals (2ndreading) using an intradermal induction concentration of 2.5%.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
12 May 1981
Deviations:
no
Remarks:
Study conducted in 1991,when TG 406 (12 May1981) was in place, prior to TG 406 (17 July1992) introducing positive control substances. Thus, the test was considered reliable despite the lack of a positive control
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
study performed before LLNA method was established
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann; Versuchstierzucht, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF
- Weight at study initiation: 352+/-22 g
- Housing: 5 animals/cage (macrolon type IV)
- Diet (e.g. ad libitum): Ssniff G 4 (Ssniff Spezialfutter GmbH, Soest), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-3°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12

- IN-LIFE DATES:
From: 30.10. To: 07.12.1990
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at intradermal induction:
50 % FCA in H2O; Test substance (2,5 %) in vehicle Test substance (2,5 %) in FCA (diluted with vehicle 1:1)
Day(s)/duration:
1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at epicutaneous induction:
Test substance 100 % FCA : Freund's Complete Adjuvant H2O: demineralized water; Vehicle: corn oil MEH 56
Day(s)/duration:
1
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Concentration / amount:
Concentration of test material and vehicle used for each challenge: a) Test substance 100 % b) Test substance 100 %
Day(s)/duration:
1
Adequacy of challenge:
highest non-irritant concentration
No.:
#2
Route:
epicutaneous, occlusive
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used for each challenge: a) Test substance 100 % b) Test substance 100 %
Day(s)/duration:
1
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
Challenge controls:
2
Positive control substance(s):
not specified
Remarks:
The study has been conducted in 1991 prior to implementation of TG 406 (July1992) introducing reliability checks with substances knowing to have sensitisation properties. Thus, the test was considered reliable despite the lack of a positive control
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100 %
No. with + reactions:
10
Total no. in group:
20
Remarks on result:
other: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 10.0. Total no. in groups: 20.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
100 %
No. with + reactions:
11
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 11.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
24
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 24.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
rechallenge
Hours after challenge:
48
Group:
negative control
Dose level:
%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Key result
Reading:
1st reading
Group:
positive control
Dose level:
not tested
No. with + reactions:
0
Total no. in group:
0
Remarks on result:
not measured/tested

Signs of skin irritation during induction

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
The substance showed to be sensitizing.
Executive summary:

The sensitizing properties of the test substance were investigated in a Magnusson & Kligman test according to OECD Guideline 406. As a result of the test, 11 out of 20 animals of the test group showed sensitization, thus the substance is to be regarded as skin-sensitizer.

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

The test item has been tested in one skin sensitization studies (Guinea pig maximization according to the Magnusson & Kligman to assess the sensitising potential of the test item. The test item induced allergic reactions in 10/20 (first reading) and 11/20 animals (second reading) using an intradermal induction concentration of 2.5%.

Based on these results the test item is regarded as skin sensitising Cat. 1B.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

There are no respiratory sensitization properties of the substance known in literature. Therefore, it might be concluded that the substance is not a respiratory sensitizer

 

Justification for classification or non-classification

Based on the positive result obtained in an in vivo study the substance should be classified as skin sensitising Category 1B according to the criteria of the Regulation (EC) No 1272/2008.