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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
26 July 1999 to 04 September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed to a valid guideline and was conducted under GLP conditions. Furthermore, the data were submitted by another legal entity, under Directive 67/548/EEC, at least 12 years previously. The registrant has been granted permission to use the following information, which has been extracted from the ECHA databases, for REACH registration purposes. The data, based on the existing registration dossier, have already passed the check for completeness on the technical dossier. The data have therefore been assigned a reliability score of 1 in line with the criteria of Klimisch (1997).
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Route:
intradermal and epicutaneous
Vehicle:
arachis oil
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 10 % in arachis oil
b) Topical Induction: 50 % in arachis oil

Concentration of test material and vehicle used for each challenge:
a) 50 % in arachis oil BP
b) 25 % in arachis oil BP
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal Induction: 10 % in arachis oil
b) Topical Induction: 50 % in arachis oil

Concentration of test material and vehicle used for each challenge:
a) 50 % in arachis oil BP
b) 25 % in arachis oil BP
No. of animals per dose:
Number of animals in test group: 10
Number of animals in negative control group: 5
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
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: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
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: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
25%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. 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:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
25%
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: 25%. 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.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
25%
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: 25%. 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 Induction:

Discrete or patchy to moderate and confluent erythema was noted at the intradermal induction sites of all test group animals at the 24-hour observation and in nine test group animals at the 48 hour observation.

Discrete or patchy erythema was noted at the intradermal induction sites of three control group animals at the 24-hour observation and in two control group animals at the 48-hour observation.

 

- Topical Induction:

Discrete or patchy erythema was noted at the induction sites of these test group animals at the 1-hour observation. No skin reactions were noted at the induction sites of test group animals at the 24-hour observation.

No signs of erythema or oedema were noted at the treatment sites of control group animals at the 1 and 24-hour observation.

Evidence of sensitisation of each challenge concentration:

Number of animals showing evidence of sensitisation at each challenge concentration: 0/10 (with 25 and 50 % concentrations)

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study the test material was determined not to be a skin sensitiser.
Executive summary:

The skin sensitisation potential of the test material was investigated in a study which was conducted under GLP conditions following the guinea pig Maximisation test method.

Under the conditions of the study the test material was determined not to be a skin sensitiser.

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

The skin sensitisation potential of the test material was investigated in a study which was conducted under GLP conditions following the guinea pig Maximisation test method.

Under the conditions of the study the test material was determined not to be a skin sensitiser.


Migrated from Short description of key information:
Not-sensitising, Maximisation test

Justification for selection of skin sensitisation endpoint:
Only one study is available.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to skin sensitisation.

In accordance with the criteria for classification as defined in Annex VI, Directive 67/548/EEC (DSD), the substance does not require classification with respect to skin sensitisation.