Registration Dossier
Registration Dossier
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EC number: 607-813-5 | CAS number: 25830-77-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Remarks:
- Due to the availability of in vivo skin irritation data no new in vitro skin irritation tests were performed
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1.2.1983 to 26.02.1986
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- none
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- EC Number:
- 607-813-5
- Cas Number:
- 25830-77-7
- Molecular formula:
- C13 H9 N O5
- IUPAC Name:
- 2-[(3S)-2,6-dioxooxan-3-yl]isoindole-1,3-dione
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: the test item was applied on a 2.5. cm square surgical lint patch to the intact skin of the rabbits
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 0ne, 24, 48, 72 and 168 hours
- Number of animals:
- 3
- Details on study design:
- The study followed the UK Health and Safety
Commission's Approved Code of Practice, 'Methods
for Determination of Toxicity', Notification of
New Substances Regulations, 1982.
Accordingly, 0.5 g aliquots of
test material were moistened with distilled water
and applied on a 2.5 cm square surgical lint
patch to the intact skin of three albino
rabbits. These were held in place by a woven
material dressing and were thus semi-occlusive.
After 4 or 7 hours (equivalent to a half or one
day working period), the patches were removed and
irritancy assessed after one, 24, 48, 72 and 168
hours according to the Draize system of
classification.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Draize classification
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- Skin irritancy after 4 hours exposition: none, according to Draize classification.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Skin irritancy after 4 hours exposition: none, according to Draize classification.
- Executive summary:
The study followed the UK Health and Safety Commission's Approved Code of Practice, 'Methods for Determination of Toxicity', Notification of New Substances Regulations, 1982.
Accordingly, 0.5 g aliquots of test material were moistened with distilled water and applied on a 2.5 cm square surgical lint patch to the intact skin of three albino rabbits. These were held in place by a woven material dressing and were thus semi-occlusive. After 4 or 7 hours (equivalent to a half or one day working period), the patches were removed and irritancy assessed after one, 24, 48, 72 and 168 hours according to the Draize system of classification.
Skin irritancy after 4 hours exposition: none, according to Draize classification.
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