Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
(Magnusson a. Kligman)
Deviations:
not specified
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
other: Pirbright white, Bor: DHPW(SPF)
Sex:
not specified
Route:
intradermal
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 2.5 % intradermal in corn oil
b) 50 % in corn oil
Concentration of test material and vehicle used for each challenge
a) 25 %
Route:
other: epicutaneous, no data on occlusion
Vehicle:
corn oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) 2.5 % intradermal in corn oil
b) 50 % in corn oil
Concentration of test material and vehicle used for each challenge
a) 25 %
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 20
Positive control substance(s):
not specified
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
20
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 20.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
18
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 18.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
1
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 1.0. Total no. in groups: 20.0.

Signs of irritation during induction: yes

Evidence of sensitisation of each challenge concentration: 20 animals

Maximum concentration not giving rise to irritation in the preliminary test:

2.5 % intradermal

25 % dermal

Interpretation of results:
sensitising
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
Based on the positive results observed in animals induced intradermally, the substance was sensitising to the skin of guinea pigs.
Executive summary:

The test substance was tested to be sensitising to the skin of guinea pigs in a GLP study according to OECD Guideline No. 406.

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

The test substance was tested to be sensitising to the skin of guinea pigs in a GLP study according to OECD Guideline No. 406 and is therefore to be classified.


Migrated from Short description of key information:
The test substance was sensitising to the skin of guinea pigs. [OECD TG 406, GLP]

Justification for selection of skin sensitisation endpoint:
GLP and guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Skin sensitisation:

Due to the positive results from a guinea pig maximisation test (OECD 406, GLP), the test material is classified as skin sensitiser (Category 1; H317: May cause an allergic skin reaction) in accordance with European Regulation (EC) No. 1272/2008.