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Toxicological information

Eye irritation

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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:
other: Non-GLP study with limited information on test material, test animals, study design and clinical examination

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
limited test material, testing animal and study design information, only 50 mg was applied to the animals which is not guideline-compliant
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Naphthalene-1,5-disulphonic acid
EC Number:
201-317-9
EC Name:
Naphthalene-1,5-disulphonic acid
Cas Number:
81-04-9
Molecular formula:
C10H8O6S2
IUPAC Name:
naphthalene-1,5-disulfonic acid
Test material form:
solid: crystalline
Details on test material:
Unspecified test material

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Duration of treatment / exposure:
single application of 0.05 g without washing
Observation period (in vivo):
7 days
Reading time points: 24, 48 and 72 h and 7 days
Number of animals or in vitro replicates:
2 (1 male, 1 female)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
1.33
Max. score:
2
Reversibility:
other: not reversible within 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
2
Reversibility:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
3
Reversibility:
other: not reversible within 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
3
Max. score:
3
Reversibility:
other: not reversible within 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean of 24, 48 and 72 h
Score:
2
Max. score:
4
Reversibility:
other: not reversible within 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean of 24, 48 and 72 h
Score:
3
Max. score:
4
Reversibility:
other: not reversible within 7 days
Other effects:
The test material was highly irritating and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Executive summary:

The test material was highly irritating in an in viov study and caused corrosion on the cornea of the rabbit eyes when applied at a dose level of 50 mg.