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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report date:
1979

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973)
Deviations:
no
GLP compliance:
no
Remarks:
not established at that time

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
EC Number:
256-050-0
EC Name:
Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate]
Cas Number:
43035-18-3
Molecular formula:
C32H26N4O7S.1/2Ca
IUPAC Name:
calcium bis(4-{[3-({2-hydroxy-3-[(4-methoxyphenyl)carbamoyl]-1-naphthyl}diazenyl)-4-methylbenzoyl]amino}benzenesulfonate)
Test material form:
solid: nanoform, no surface treatment

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Frankfurt, Germany
- Weight at study initiation: 1.5 - 2.5 kg
- Housing: single
- Diet: standard diet (ERKA 8300, Futtermittelwerke Robert Koch , Hamm. Germany), ad libitum
- Water: ad libitum

Test system

Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg pasted with 0.25 ml physiol. saline.
Duration of treatment / exposure:
24 h
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with physiological saline
- Time after start of exposure: 24 h

SCORING SYSTEM: basically in accordance with OECD TG 405.
Scores were read 1, 7, 24, 48 and 72 h after test substance application.

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein at 48 and 72 h reading

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
iris score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
2
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
3
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritation parameter:
chemosis score
Basis:
animal: # 1, 2, 3, 4, 5, 6 each
Time point:
other: mean of the 24, 48 and 72 h reading
Score:
0
Max. score:
4
Reversibility:
other: reversibility not relevant since no effect
Remarks on result:
other: Readings took place 24, 48 and 72 h after instillation. Means thereof were claculated for each rabbit.
Irritant / corrosive response data:
- no effects were observed at any time point.
- no discharge was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material was not irritating to eyes in all animals under test conditions which are basically in accordance with todays standard methods regarding dosing, exposure duration, scoring system and reading time points.
Executive summary:

Test material was subject to a test of eye irritancy according to FDA guidelines (Fed. Reg. Vol. 38, No. 187, p. 27019, 1973). 100 mg of substance were applied to one eye of each of six animals. The eyes were washed 24 h after application and eye responses were noted for 72 h. No responses of the eyes were observed within 72 hours after application. Therefore, it is concluded that the submission substance is not irritating to eyes.