Registration Dossier

Administrative data

Description of key information

The test item is considered to possess no skin-sensitizing (contact allergenic) potential in albino-guinea pigs.

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:
01 Okt 1979 to 22 Jan 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study
Qualifier:
according to
Guideline:
other: Appraisel of the Safety of Chemicals in Foods, Drugs and Cosmetics (US 1959)
GLP compliance:
no
Type of study:
Maurer optimisation test
Justification for non-LLNA method:
Currently no LLNA study is available for assessment. The Maurer optimisation test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Bantin and Kingman Ldt. Grimston, Hull, England
- Weight at study initiation: 305 to 400 g
- Housing: The animals were housed individually in Macrolon cages
- Diet: The animals received ad libitum standard guinea pig pellets - NAFAG, No. 830, Gossau SG - and water

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 10 hours light cycle day
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
0.1 % suspension of the test substance
Day(s)/duration:
1st week: 1 intracutaneous injection every second day
Route:
intradermal
Vehicle:
other: (propylen glycol : Bacto Adjuvant) = 1:1
Concentration / amount:
0.1% suspension of the test substance
Day(s)/duration:
2nd & 3rd week: 1 intracutaneous injection every second day
No.:
#1
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
0.1 mL of 0.1 % suspension of the test substance
Day(s)/duration:
14 days after the last sensitising injection
No.:
#2
Route:
other: epicutaneous
Vehicle:
other: vaseline
Concentration / amount:
30 % suspension of the test substance
No. of animals per dose:
10 males and 10 females per group
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Three different injection procedures + challenge exposure + epicutaneous application:
1. One injection every second day to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension of the test item in propylene glycol
2. On the first day, injection of 0.1 mL were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back.
3. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1)

- Exposure period: 3 weeks
- Test groups: group of 10 males and 10 females
- Control group: one control group was treated with the vehicle alone (negative control)

B.1 CHALLENGE EXPOSURE (intradermal)
- Exposure period: fourteen days after the last sensitizing injection, a challenge injection of 0.1 mL of a freshly prepared 0.1 % suspension of the test item in propylene glycol was administrated into the skin of the left flank

B.2 CHALLENGE EXPOSURE (epidermal)
- 30 % suspension of the test item in vaseline
Positive control substance(s):
no
Positive control results:
no positive controls
Key result
Reading:
other: first reading (intradermal challenge)
Hours after challenge:
24
Group:
test group
Dose level:
0.1 %
No. with + reactions:
18
Total no. in group:
20
Reading:
other: first reading (intradermal challenge)
Hours after challenge:
24
Group:
negative control
No. with + reactions:
4
Total no. in group:
20
Remarks on result:
other: negative control
Remarks:
no concentration can be applied
Key result
Reading:
other: first reading (epicutaneous challenge)
Hours after challenge:
24
Group:
test group
Dose level:
30 %
No. with + reactions:
0
Total no. in group:
20
Reading:
other: first reading (epicutaneous challenge)
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: negative control
Remarks:
no concentration can be applied

Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after intradermal challenge application of the test item, i.e. when the skin barrier was intentionally by-passed.

No differences between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.

Interpretation of results:
GHS criteria not met
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A skin sensitisation test in Pirbright-Hartley guinea pigs was performed with the test substance (BASF, 1980) according to the method recommended in the "Appraisel of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) from the US Association of Food and Drug Officials (AFDO) and equal to OECD guideline 406.

During the induction period 20 animals (10 males, 10 females) received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a 0.1% suspension of the test substance in propylene glycol. One control group was treated with the vehicle alone. On the first day, injections of 0.1 mL were administered into the shaven skin of the right flank and the back, while on the following days a single intracutaneous injection was given into the back. During the second and third week of the induction period the test material was incorporated in a mixture of the normal vehicle with complete Bacto Adjuvant (vehicle : adjuvant = 1 : 1). Fourteen days after the last sensitizing injection, a challange injection of 0.1 mL of a 0.1 % suspension of the test substance in propylene glycol was administered into the skin of the left flank. Ten days after the intracutaneous challange injection, 30% of the test item in vaseline as applied epicutaneously under occlusive dressing which were left in place for 24 hours.

Under the experimental conditions employed, significant differences between the test group and the vehicle-treated controls were only seen after intradermal challenge application of the test substance, i.e. when the skin barrier was intentionally by-passed. No difference between the test and the control group was seen after epidermal challenge application. The negative results upon epidermal challenge demonstrate that, in artificially sensitized guinea-pigs, exposure of the intact skin to the test compound does not provoke contact dermatitis.



Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the available information, the substance does not need to be classified for skin sensitisation in accordance with EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation No. (EC) 1272/2008.