Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Carbon Black-DSM Roetolie
- Batch number: UN:2810, batch number. 16-5-89
- Substance type: Mixture of high boiling aromatic hydrocarbons
- Physical state: dark brown viscous liquid
- Analytical purity: not applicable
- Storage: room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Sex: male
- Weight at study initiation: 2700-2870 g
- Housing: individually in suspended, galvanized cages, fitted with a wire mesh floor and front
- Diet: standard laboratory rabbit diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 3°C
- Humidity: at least 40%
- Air changes (per hr): approx. 10
- Photoperiod: natural day/night cycle

IN-LIFE DATES: From: 22 May 1989 To: 25 May 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Corneal opacity on a 0-4 scale, iritis on a 0-2 scale, conjunctival redness on a 0-3 scale, conjunctival chemosis on a 0-4 scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: no iridial effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: minimal redness in 3 animals 1- 24 hours and 1 animal at 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: minimal chemosis in 3 animals 1- 24 hours and 1 animal at 48 hours
Irritant / corrosive response data:
After 1 hour slight redness with or without slight swelling of the conjunctivae. At 24 hours slight redness and slight swelling of the conjunctivae. At 48 hours the eye effects had cleared completely in two of the three rabbits, whereas slight redness and slight swelling of the conjunctivae were observed in the third rabbit. All irritation had cleared by 72 hours.
Other effects:
The test substance adhered to the hair surrounding the eye in all 3 rabbits.

Any other information on results incl. tables

Eye irritation scores of Carbon Black-DSM Roetolie

Time

Cornea

Iris

Conjunctiva

 

 

 

 

Redness

Chemosis

 

Animal number

63

73

74

63

73

74

63

73

74

63

73

74

after 1 hour

0

0

0

0

0

0

1

1

1

1

0

0

after 24 hours

0

0

0

0

0

0

1

1

1

1

1

1

after 48 hours

0

0

0

0

0

0

0

0

1

0

0

1

after 72 hours

0

0

0

0

0

0

0

0

0

0

0

0

mean scores 24-72h

0

0

0

0

0

0

0.3

0.3

0.7

0.3

0.3

0.7

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Carbon Black-DSM Roetolie is not irritating to eyes.
Executive summary:

Eye irritation potential of carbon black-DSM Roetolie (CAS 64742-90-1) was determined in a group of three albino rabbits.

There was no evidence of damage to the cornea or iris throughout the study. Conjunctival redness and chemosis was seen from 1 hour to 48 hours after application. Mean scores over 24, 48 and 72 hours were: cornea 0, iris 0, conjunctival redness 0.4, chemosis 0.4.

Carbon black-DSM Roetolie (CAS 64742-90-1) was not irritating to the rabbit eye and does not warrant classification under Dir 67/548/EEC or GHS CLP.