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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 20-27, 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report date:
1981

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate
EC Number:
225-948-4
EC Name:
Sodium 2-methyl-2-[(1-oxoallyl)amino]propanesulphonate
Cas Number:
5165-97-9
Molecular formula:
C7H13NO4S.Na
IUPAC Name:
sodium 2-(acryloylamino)-2-methylpropane-1-sulfonate
Details on test material:
- Name of test material (as cited in study report): OS#48933E
- Physical state: liquid
- Analytical purity: >99%
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: young adult
- Weight at study initiation: not specified
- Housing: individual cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21.2 (68-72°F)
- Humidity (%): 45-50
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 20/10/1981 To: 27/10/1981

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
- Concentration: 50% (undiluted)
Duration of treatment / exposure:
Single application (unwashed)
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
0
Reversibility:
fully reversible within: 24 hours
Irritant / corrosive response data:
Moderate conjuctival irritation was apparent in the dosed eyes of all 6 rabbits. All rabbits had a normal ocular appearance within 72 hours to 4 days.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was considered to be not irritating to eyes under the test conditions.