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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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, other
Remarks:
non LLNA
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific principles, acceptable for assessment. GLP compliant including certificate.
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Existing study well reported and performed under GLP.
Species:
guinea pig
Strain:
Himalayan
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- number of animals: 5 males / 5 females in pre-test and 10 males/10 females for the test- Weight at study initiation: 332 - 412 g- Housing: Individually in Makrolon type-3 cages with standard softwood bedding - Diet : Pelleted standard NAFAG No. 845; guinea pig breeding/ maintenance diet, ad libitum.- Water: tap water , ad libitum. ENVIRONMENTAL CONDITIONS- Temperature (°C):22 ± 3°C- Humidity (%): 30-70 %- Photoperiod : 12 hours artificial fluorescent light/12 hours dark.
Positive control results:
No data
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were observed.
Remarks on result:
other: No systemic symptoms were observed..
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No systemic symptoms were obseved.
Remarks on result:
other: No systemic symptoms were obseved.
Interpretation of results:
other: not sensitizing
Conclusions:
According to EEC (European Economie Community) and CLP classification criteria described in guidelines 83/467, September 16, 1983, the tested substance is not a sensitizer.
Executive summary:

The purpose of this skin sensitization study was to assess the allergenic potential of the tested substance when administered to the skin of albino guinea pigs following OECD 406, Maximization-Test of B. Magnusson and A.M. Kligman (1969).

No skin reactions were observed in the test group and the tested substance could be considered as not skin sensitizer.

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

The results of the available test and report on evaluation of dermal effects on human showed no sensitizing effects.

Therefore the tested substance should not be considered to be a sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The tested substance should not be considered to be a sensitizer according to Regulation CE 1272/2008.