Registration Dossier

Administrative data

Description of key information

In vivo guinea pig maximisation test (OECD 406)

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Study was conducted prior to REACH regulations.
Specific details on test material used for the study:
TEST MATERIAL NAME (as stated in study report): TK 12437 (Irgastab CH 302)

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor; Batch No. 08520495
- Expiration date of the lot/batch: July, 1996
- Purity: within the product specifications

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: in house
- Weight at study initiation: 320 to 398 g
- Housing: individually in Macrolon cages (Type 3)
- Diet (e.g. ad libitum): Standard guinea pig pellets - NAFAG No. 845, Gossau SG; ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 / 12
Route:
intradermal
Vehicle:
other: Oleum arachidis
Concentration / amount:
5% / 0.1 mL
Day(s)/duration:
Single injection during Week 1
Adequacy of induction:
other: Concentration selected based on solubility of the test article and its local and systemic tolerability in a pretest.
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
50% / 0.4 g
Day(s)/duration:
Single application during Week 2. Applied for 48 hours
Adequacy of induction:
other: Concentration selected based on primary Irritation potential
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
10% / 0.2 g
Day(s)/duration:
Single application during Week 5. Applied for 24 hours
No. of animals per dose:
Test group: 10 males and 10 females
Control group; 5 males and 5 females
Details on study design:
see above
Challenge controls:
A control group of 10 animals (5 m/5 f) was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test article to check the maximum subirritant concentration of the test article in adjuvant treated animals.
Positive control substance(s):
no
Remarks:
The sensitivity of the strain is checked once or twice a year with a known mild to moderate sensitiser, such as mercaptobenzothiazole, hexyl cinnamic aldehyde or potassiumdichromate.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
17
Total no. in group:
20
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
10%
No. with + reactions:
16
Total no. in group:
20
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
10

see attached summary table

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
In a guideline (OECD 406) in vivo GMPT study, Irgastab CH 302 was a skin sensitizer in albino guinea pigs. 85% of the test animals were sensitized at an induction concentration of 5%.
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

85% of the test animals were sensitized at an induction concentration of 5%.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available data, Irgastab CH 302 is classified as a Category 1B skin sensitizer according to Regulation (EC) No 1272/2008.