Registration Dossier

Administrative data

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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
not specified
Sex:
not specified
Route:
intradermal and epicutaneous
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
50% epidermal in corn oil.
10% intradermal in corn oil.

Concentration of test material and vehicle used for each challenge:
50%
Route:
other: epicutaneous
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
50% epidermal in corn oil.
10% intradermal in corn oil.

Concentration of test material and vehicle used for each challenge:
50%
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
7
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50%. No with. + reactions: 7.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
9
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 9.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Maximum concentration not causing irritating effects in preliminary test: 50%

Signs of irritation during induction:

Intradermal 10% test substance concentration:

9/10 animals - Necrosis varying between 2 and 4 mm

1/10 animals - Erythema grade 2

Epidermal exposure 50%:

10/10 animals - Erythema

8/10 animals - Odema (varying between grade 1 and 2).

Evidence of sensitisation of each challenge concentration:

9/10 animals.

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The skin reactions observed in response to a 50% test substance concentration in nine (of the ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals. The substance is classified as a skin sensitiser.
Executive summary:

The test substance was assessed for skin sensitisation according to EU Method B6 in guinea pigs.

In preliminary tests, the maximum concentration not causing irritating effects was 50 %. During the test, the skin reactions observed in response to a 50% test substance concentration in nine (out of ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.

The substance is therefore classified as a skin sensitiser.

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

The test substance was assessed for skin sensitisation according to EU Method B6 in guinea pigs.

In preliminary tests, the maximum concentration not causing irritating effects was 50 %. During the test, the skin reactions observed in response to a 50% test substance concentration in nine (out of ten) experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of any response in the control animals.

The substance is therefore classified as a skin sensitiser.


Migrated from Short description of key information:
The skin reactions observed in response to a 50% test substance concentration in nine (out of ten) experimental animals in the challenge phase were considered indicative of sensitisation.

Justification for selection of skin sensitisation endpoint:
Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for use for the substance being registered.
Study conducted in accordance with generally accepted scientific principles.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test substance was assessed for skin sensitisation according to EU Method B6. Nine out of the ten animals tested had a positive reaction to the test substance at a 50 % concentration. The test substance should therefore be classified as a skin sensitiser in accordance with the criteria outlined in Regulation (EC) 1272/2008/EC (CLP) or Directive 67/548/EEC (DSD).

The substance is therefore classified as a skin sensitiser.

Based on Regulation (EC) No 1272/2008 (CLP) the results would indicate that the tested substance is a moderate sensitiser, based on the criteria of ≥ 30 % animals responding at > 1 % intradermal induction dose. This would result in classificaiton in sub-category 1B. However, as the results have been read-across from a comparable substance, is substance itself will be classified as Category 1 and a sub-category not selected.