Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion
Remarks:
other: Assessment and expert judgement
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), 8.1, the "assessment of this endpoint shall comprise the following consecutive steps:
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline reserve,
(3) in vitro study for skin corrosion,
(4) in vitro study for skin irritation."
See below for criteria for derogation of Steps 3 and 4
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
other: not required
Strain:
other: not required

Test system

Type of coverage:
other: not required
Preparation of test site:
other: not required
Vehicle:
other: not required
Controls:
not required

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), 8.1, the assessment of this endpoint comprises the following consecutive steps:

(1) an assessment of the available human and animal data: The registrant has no skin irritation/corrosion data available.

(2) an assessment of the acid or alkaline reserve: The molecular weight of the substance is 122 g/mole. If the substance is mixed with small amounts of water, due to hydrolyzis, up to aproximately 8 moles/kg of 3-hydroxopropanesulfonic acid may be formed

(3) in vitro study for skin corrosion,

(4) in vitro study for skin irritation.

An in vitro study for skin corrosion and an in vitro study for skin irritation do not need to be conducted if :

— "the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes".

This criterium is established since corrosive substances are - in general - not unawarely in contact with the skin. 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

Executive summary:

The assessment of this endpoint comprised the following consecutive steps:

(1) an assessment of the available human and animal data: The registrant has no skin irritation/corrosion data available.

(2) an assessment of the acid or alkaline reserve: The molecular weight of the substance is 122 g/mole. If the substance is mixed with small amounts of water, due to hydrolyzis, up to aproximately 8 moles/kg of3-hydroxopropanesulfonicacidmay be formed

(3) in vitro study for skin corrosion,

(4) in vitro study for skin irritation.

An in vitro study for skin corrosion and an in vitro study for skin irritation had not to be performed because "the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes.

This criterium is established since corrosive substances are - in general - not unawarely in contact with the skin. As the substance is classified as a CMR substance, at least, the same level level of protection is reached and no test is required.