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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
other: cross reference to literature data
Adequacy of study:
weight of evidence
Study period:
not specified
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Unnamed
Year:
2008
Report Date:
2008
Reference Type:
publication
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Standard Draize Test
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Colour: colourless
- Odour: odourless
- CAS-Number: 89-32-7
- Molecular formula: C10 H2 O6
- Molecular weight: 218.12

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
24 hours in standard draize test
Observation period (in vivo):
24, 48 and 72 hours (up to 21 days) in strandard draize test
Duration of post- treatment incubation (in vitro):
no data
Number of animals or in vitro replicates:
no data
Details on study design:
no data

Results and discussion

In vivo

Results
Irritation parameter:
other: not specified
Basis:
other: not specified
Time point:
other: not specified
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
The substance was observed to cause severe eye irritation, leading to a classification as serious eye damage (Cat. 1).

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The substance needs to be considered as severe eye irritant, cat. 1.
Executive summary:

Substance is listed in the consolidated version of EU Regulation 1272/2008 as corrosive, leading to a classification as serious eye damage (Cat. 1).  The substance is highly reactive and hydrolyzes in contact with water or body fluids to the corresponding pyromellitic acid; measured ph-value of hydrolyzed material in water is 2. In literature, the substance is reported to be severly irritant to eyes in a standard Draize test, therefore it was decided to take over this classification and to conduct no further studies.