Registration Dossier
Registration Dossier
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EC number: 295-310-8 | CAS number: 91995-49-2 A complex combination of organic compounds obtained as a filtrate from the crystallization of the naphthalene fraction from coal tar and boiling in the range of approximately 200°C to 230°C (392°F to 446°F). Contains chiefly naphthalene, thionaphthene and alkylnaphthalenes.
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, basic data given
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission, USA; Code of Federal Regulations, Title 16, Section 1500.42
- Principles of method if other than guideline:
- The method used is similar to the OECD test guideline 405 (Acute Eye Irritation/Corrosion) with some deviations (first observation 24 h after application, differing scoring system, limited reporting)
- GLP compliance:
- no
Test material
- Reference substance name:
- Naphthalene
- EC Number:
- 202-049-5
- EC Name:
- Naphthalene
- Cas Number:
- 91-20-3
- Molecular formula:
- C10H8
- IUPAC Name:
- Naphthalene
- Details on test material:
- - Name of test material (as cited in study report): Produkt 104.111
- Physical state: white powder
- Melting point: ~ 79.5 °C
- Analytical purity: no data
- Storage condition of test material: room temperature
- Fraction in Naphthalene oil: > 35 %
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino rabbits
- Details on test animals or tissues and environmental conditions:
- no data
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: second eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g - Duration of treatment / exposure:
- 24 h
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to Draize (ETAD recommendation)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 2.67
- Max. score:
- 110
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 2.17
- Max. score:
- 110
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: day 1, 2, and 3
- Score:
- 0.056
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: day 1, 2, and 3
- Score:
- 0.389
- Max. score:
- 3
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: day 1, 2, and 3
- Score:
- 0.111
- Max. score:
- 4
- Reversibility:
- fully reversible within: 2 days
Any other information on results incl. tables
Individual scores (according to Draize)
|
Rabbit 1 |
Rabbit 2 |
Rabbit 3 |
Rabbit 4 |
Rabbit 5 |
Rabbit 6 |
|||||||||||||||||||
Observation time (day) |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
1 |
2 |
3 |
4 |
|
Cornea |
Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Conjunctivae |
Redness |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Chemosis |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Discharge |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Total score (according to Draize, summation over all rabbits)
Day |
1 |
2 |
3 |
7 |
Total score |
16 |
13 |
0 |
0 |
Following instillation of the test compound, none of the test animals showed any reaction of the cornea. An iris reaction was only seen in one rabbit at day 2 (grade 1). Conjunctiva redness grade 1 was observed in 5 rabbits over a period of maximal two days and slight chemosis (grade 1) was noted in one rabbit at day 1. All effects had subsided at day 3.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Eye reactions were minor and could only be noted at day 1 and 2 of the observation period (iris reaction, conjunctivae redness, and chemosis, score 1 or 2). Effects had disappeared at day 3. Cut-off scores for classification as irritating to the eye according to EU regulations have not been exceeded.
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