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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed according to OECD Guideline n° 405 and in compliance with UK GLP standards.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate
IUPAC Name:
reaction mass of calcium sulfate,magnesium dihydroxide,calcium carbonate

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
water
Controls:
not required
Amount / concentration applied:
0.1 ml of the test material
Duration of treatment / exposure:
the test material was not removed
Observation period (in vivo):
1, 24, 48, 72 hours and after 7 days
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
16.3
Max. score:
17
Reversibility:
fully reversible
Remarks:
All treated eyes appeared normal at the 7-day observation
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
15.7
Max. score:
29
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
9.7
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
7.7
Max. score:
15
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to Commission Directive 93/21/EEC.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a maximum group mean score of 16.3 and was classified as a moderate irritant (class 5 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance should not be classified for eye irritation/corrosion using the criteria of Directive 67/548/EEC (DSD) or the criteria of Regulation No 1272/2008 (CLP).