Registration Dossier

Administrative data

Endpoint:
skin sensitisation
Remarks:
other: Assessment of existing data and expert judgemnt
Type of information:
other: Assessment and expert judgement
Adequacy of study:
key study
Study period:
2011
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Expert judgement. Basic data given. Reliable source

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Principles of method if other than guideline:
According to Annex VII "Standard Information Requirements for Substances Manufactured or Imported in Quantities of one Tonne or More" of the "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC” (as amended) (OJ L 396, 30.12.2006, p.1) 8.3, the "assessment of this endpoint shall comprise the following consecutive steps:
(1) an assessment of the available human, animal and alternative data,
(2) In vivo testing"
GLP compliance:
no
Type of study:
other: Expert judgement

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
not applicable

In vivo test system

Test animals

Species:
other: not applicable

Results and discussion

Any other information on results incl. tables

According to Annex VII "Standard Information Requirements for Substances Manufactured or Imported in Quantities of one Tonne or More" of the "Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC” (as amended) (OJ L 396, 30.12.2006, p.1) 8.3, the assessment of this endpoint comprised the following consecutive steps:

(1) an assessment of the available human, animal and alternative data: no reports on adverse effects identified

(2) In vivo testing had not to be performed because

— the available information indicates that the substance should be classified for skin corrosivity.

No in vitro study had to be performed because the available information indicates that a extremely high level of protection is reached.

Corrosive substances are exempted from testing because - in general - they not unawarely in contact with the skin or eye. As the substance is classified as a CMR substance, at least, the same level level of protection is reached and no test is required.

Applicant's summary and conclusion

Interpretation of results:
other: not relevant
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Required level of Protection reached if substance is handled under strictly controlled conditions.
Executive summary:

No in vitro study had to be performed because the available information indicates that a extremely high level of protection is reached.

Corrosive substances are exempted from testing because - in general - they not unawarely in contact with the skin or eye. As the substance is classified as a CMR substance, at least, the same level level of protection is reached and no test is required.