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Diss Factsheets

Administrative data

Description of key information

A study was conducted to evaluate the skin sensitisation potential of the test substance as per the maximization test recommended in the OECD Guideline 406 and EEC directive 79/83. The test was performed on 10 male and 10 female guinea pigs per group weighing between 315-439 g (approx. 10 weeks old). The induction was a two-stage operation: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. For intradermal induction, the test substance was administered at the concentration of 5% in physiological saline and adjuvant mixture. For epicutaneous induction, approximate 0.4 g paste of 30 % test substance in vaseline was applied. Two weeks after the epidermal induction application the animals were challenged on the flank with approximate 0.2 g paste of 1 % test substance in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, based on the findings of the study, the test substance was classified as a non-sensitiser.

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:
15 Oct, 1985 to 26 Nov, 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
no
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Data from a reliable in vivo test conducted before the enforcement of Commission Regulation (EU) 640/2012 of 06 July 2012 amending, for the purpose of its adaptation to technical progress, Regulation (EC) No. 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) are available.
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Identified as: FAT 40068/C
- Source and batch no.of test material: EN 86527.22
- Expiration date of the batch: April, 1990
- Contents of active ingredient: 70 %

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: Guaranteed by the sponsor

OTHER SPECIFICS:
- Physical properties: Powder
- Safety precautions: Gloves and face masks
Species:
guinea pig
Strain:
other: Pirbright White Strain (Tif: DHP)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: approx. 10 weeks old
- Weight at study initiation: 315 - 439 g
- Housing: Individually in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No.846, Gossau SG
- Water: ad libitum fresh water
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.

- IN-LIFE DATES: From: October 15, 1985 To: November 15, 1985
Route:
intradermal
Vehicle:
physiological saline
Concentration / amount:
5 %
Day(s)/duration:
Day 1
Adequacy of induction:
highest technically applicable concentration used
Route:
epicutaneous, occlusive
Vehicle:
other: Vaseline
Concentration / amount:
30 %
Day(s)/duration:
Day 8
Adequacy of induction:
highest technically applicable concentration used
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: vaseline
Concentration / amount:
1 %
Day(s)/duration:
Day 22
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 males and 10 females
Details on study design:
RANGE FINDING TESTS: The concentration of the test compound for the induction and challenge periods were determined on separate animals.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: Two (1 intradermal + 1 epicutaneous)
- Exposure period: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later for 24 hours.
- Site: Intradermal induction- Shaved neck of the guinea pigs, epicutaneous induction- neck of the animals previuosly used for intradermal induction.
- Frequency of applications: Once each for intradermal and epicutaneous inductions
- Duration: epicutaneous induction- 48 hours
- Concentrations: intradermal induction - 5 %, epicutaneous induction: 30 %

B. CHALLENGE EXPOSURE
- No. of exposures: One
- Day(s) of challenge: Two weeks after the epidermal induction application
- Exposure period: 24 hours
- Site: On the flank
- Concentrations: 1 %
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
A control group 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 compound (at least 10 animals) to control the maximal subirritant concentration of the test compound in adjuvant treated animals.
Positive control substance(s):
yes
Remarks:
The sensivity of the strain is checked every six months with Paraphenylene-diamine or Potassium-dichromate.
Positive control results:
Not specified
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5% Intradermal and 30% Epicutaneous induction. 1% Epidermal challenge
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5% Intradermal and 30% Epicutaneous induction. 1% Epidermal challenge
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
no indication of skin sensitisation
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance was classified as a non-sensitiser.
Executive summary:

A study was conducted to evaluate the skin sensitisation potential of the test substance as per the maximization test recommended in the OECD Guideline 406 and EEC directive 79/83. The test was performed on 10 male and 10 female guinea pigs per group weighing between 315-439 g (approx. 10 weeks old). The induction was a two-stage operation: First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. For intradermal induction, the test substance was administered at the concentration of 5% in physiological saline and adjuvant mixture. For epicutaneous induction, approximate 0.4 g paste of 30% test substance in vaseline was applied. Two weeks after the epidermal induction application the animals were challenged on the flank with approximate 0.2 g paste of 1 % test substance in vaseline and the vehicle alone (patch 2 x 2 cm; occluded administration for 24 hours). Twenty four hours after removing the dressings, the challenge reactions were graded according to the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. Under the experimental conditions employed, 0 % of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Hence, based on the findings of the study, the test substance was classified as a non-sensitiser.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of a skin sensitisation study, the test substance does not warrant classification as per the criteria of CLP (1272/2008) Regulation.