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EC number: 701-299-7 | CAS number: -
Eye irritation
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:
- test procedure in accordance with national standard methods with acceptable restrictions
- Remarks:
- Pre-GLP study, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- pre-guideline study
- Principles of method if other than guideline:
- The test procedure follows the test method described in "TEST FOR EYE IRRITANTS" from US Code of Federal Regulation (CFR), Title 16, Section 1500.42, which is comparable to OECD TG 405.
- GLP compliance:
- no
- Remarks:
- pre-GLP study
Test material
- Reference substance name:
- Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised
- EC Number:
- 701-299-7
- Molecular formula:
- not applicable (depends on the monomers; see "Structural formula")
- IUPAC Name:
- Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised
- Test material form:
- liquid: viscous
- Details on test material:
- - Manufacturers identification: Novares TL 10, Novares L 100, Novares L 800, Novares C 10 (different types/technical products of the substance)
- Substance type: organic
- Test material is 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised', EC list number 701-299-7 (assigned by ECHA after request for change of EC number/EC name). Originally, the substance Hydrocarbons, C9-unsaturated, polymerised, CAS No. 71302- 83-5, was submitted for registration. Subsequent to substance validation, the identity of the substance was changed by ECHA (EC number 615-276-2 and new name 'Distillates (petroleum), steam-cracked, C8-12 fraction", mainly C8 - C10 unsaturated aromatic and alkylaromatic hydrocarbons, predominantly styrene- and indene-derivatives, obtained by Lewis acid-initiated alkylation and polymerisation').
- for additional information see respective study records
1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): Produkt-Nr.: 161 001 (additional name: Cumaron-Inden Harz B1 flüssig) (early technical product of the substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised')
- no further information
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- albino rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Details unknown
ENVIRONMENTAL CONDITIONS
- Details unknown
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- according to method description in the study report
- Controls:
- not required
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE:
- Washing (if done): no data
SCORING SYSTEM: according to Draize, published by Food and Drug Officials of the USA, 1959 (see below); in this system, scores are included for the area of cornea affected and for discharge. Total maximum score is 110.
TOOL USED TO ASSESS SCORE: ETAD classification scheme (see below)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 1.4
- Max. score:
- 110
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no effects observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.278
- Max. score:
- 3
- Reversibility:
- fully reversible within: 2 days
- Remarks on result:
- other: effects were only noted at the 24 h reading (5 animals with score 1). At later time points, no effects were observed
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0.389
- Max. score:
- 4
- Reversibility:
- fully reversible within: 3 days
- Remarks on result:
- other: chemosis was note in 4 animals at the 24 h reading (score 1) and in 3 animals at the 48 h reading (score 1). Effects had subsided at day 3
- Irritant / corrosive response data:
- Six animals were tested for eye irritation response. No effects were noted at the cornea and iris of the test animals. Conjunctival redness and oedema (chemosis) observed in some animals were only low grade (maximum score 1). Conjunctival redness had subsided at day 2 (48-h reading), and chemosis had disappeared at day 3 (72-h reading). Responses for corneal opacity, iritis, conjunctival redness and/or chemosis above the criteria for eye irritation of Regulation (EC) 1272/2008 (CLP regulation) were not observed in any animal.
Any other information on results incl. tables
Individual scores
Animal No. |
Examination of |
Day |
||||
1 |
2 |
3 |
7 |
|||
1 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
||
Draize score |
|
4 |
2 |
0 |
0 |
|
2 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
||
Draize score |
|
4 |
2 |
0 |
0 |
|
3 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
||
Draize score |
|
2 |
0 |
0 |
0 |
|
4 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
1 |
0 |
||
Draize score |
|
2 |
0 |
2 |
0 |
|
5 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
1 |
1 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
||
Draize score |
|
4 |
2 |
0 |
0 |
|
6 |
Cornea |
Opacity |
0 |
0 |
0 |
0 |
Area |
0 |
0 |
0 |
0 |
||
Iris |
|
0 |
0 |
0 |
0 |
|
Conjunctiva |
Redness |
1 |
0 |
0 |
0 |
|
Chemosis |
0 |
0 |
0 |
0 |
||
Discharge |
0 |
0 |
0 |
0 |
||
Draize score |
|
2 |
0 |
0 |
0 |
|
|
Total Draize score |
18 |
6 |
2 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This test material representing the substance NAF-AO is not irritating to the eye compared to current test standards.
- Executive summary:
In this study, the test material (0.1 mL) was applied to one eye of each of six test animals (albino rabbits). The rabbits were observed for 7 days. Readings were taken at 24, 48, and 72 hours using the scoring system of Draize (published by the Food and Drub Officials of the United States, 1959). Results indicate that application of the test material caused slight but non classifiable irritation to the eye.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
