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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:
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:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
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
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.