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Description of key information

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:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The LLNA was not available at time of study implementation. Existing data from Buehler study scientifically adequate.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Hall Limited, UK
- Age at study initiation: approximately 8 - 12 weeks
- Weight at study initiation: < 300 g
- Housing: polypropylene cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 -23 °C
- Humidity (%): 30 - 70%
- Air changes (per hr): 15 per hour
- Photoperiod (hrs dark / hrs light): 12 hours

Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
Intradermal induction: 0.1% v/v in distilled water
Topical induction: 5% v/v in distilled water
Topical challenge: 5% and 1% v/v in distilled water
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Intradermal induction: 0.1% v/v in distilled water
Topical induction: 5% v/v in distilled water
Topical challenge: 5% and 1% v/v in distilled water
No. of animals per dose:
10 test animals
5 control animals
Positive control substance(s):
yes
Remarks:
periodically tested two times per year
Positive control results:
Positive control study confirmed validity of test system
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
1%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
1%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no.
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item produced a 0% (0/10) sensitisation rate and was classified as a non-sensitizer to guinea pig under the conditions of the test.
Executive summary:

The sensitization potential of the test item was investigated using the maximization method according to Magnusson and Kligman (OECD TG 406) in guinea pigs in accordance with the principles of GLP. 10 male test and 5 male control animals were used for the study. For selection of the test concentrations to be used in the main study, irritation screens following intradermal and topical administration of test substance were performed. After intradermal injection of 0.1, 0.5, 1 and 5% (v/v) the degree of erythema was assessed. Due to severe skin reactions the animals treated with 1% and 5% were killed for humane reasons following the 24 hour observation. 0.1% causing mild to moderate irritation was selected for the intradermal induction treatment for the main study. Screening for topical induction concentrations were performed using 75%, 50%, 25%, 5%, 1%, 0.5% and 0.1% (v/v) test substance in water. Due to severe dermal reactions the animals treated with 25% and higher were killed for humane reasons immediately after the 1 hour observation. 5% test item in water which was tolerated systemically and produced only mild to moderate dermal irritation was selected for the topical induction stage of the main study and 5% as well as 1% for the dermal challenge tretament. Patches for both topical induction and challenge were kept in contact with the skin under occlusive conditions for 48 and 24 hours respectively. Following the topical induction, discrete or patchy to moderate erythema was elicited by the test material in all animals from the test and control group. However, no skin reactions were noted at the challenge sites (5% and 1%) of the test or control group animals at the 24 or 48 hour observations. Based on the results, the test item produced a 0% (0/10) sensitisation rate and is considered to be a non-sensitiser to guinea pigs under the conditions of the test.

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

The sensitization potential of the submission substance was investigated in an guideline conform maximization test in male guinea pigs according to magnusson and Kligman. 10 test and 5 control animals were used. Based on the results of sighting tests, 0.1% (v/v) for the intradermal induction, 5% (v/v) for the topical sensitization as well as 5% and 1% (v/v) for the dermal challenge phase were selected as concentrations of the test material. As vehicle distilled water was used. Under the conditions of this test, the submission substance produced a 0% (0/10) sensitization rate and was classified as a non-sensitizer to guinea pigs.


Migrated from Short description of key information:
A guideline conform maximization test according to Magnusson and Kligman (OECD TG 406) in guiena pigs with the submission substance showed no evidence for skin sensitising properties.

Justification for selection of skin sensitisation endpoint:
Guideline study according to GLP with a Klimisch rating of 1

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

With regard to respiratory tract sensitisation the submission substance is not considered to exert sensitizing effects on the respiratory tract. Due to its severe irritating / corrosive properties and a related self-warning effect any inhaltion exposure will be minimized. Additionally, from a guideline conform maximization test, no indications concerning sensitizing properties exist.


Migrated from Short description of key information:
With regard to respiratory tract sensitisation the submission substance is not considered to exert sensitizing effects on the respiratory tract and is not classified for this endpoint.

Justification for classification or non-classification

A guideline conform maximization study (OECD TG 406) with the submission substance showed no evidence for sensitising properties.

Thus, it can reasonably be deduced that the submission substance does also not cause respiratory tract sensitization and thus does not have to be classified according to the criteria laid down in the EU Dangerous Substances Directive (67/548/EEC) and in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).