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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
Study period:
09. Sept. 1986 - 15. Sept. 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable study report, which meets basic scientific priniciples

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Tetrabutan (dest.)
- Physical state: liquid
- Isomers composition: C16-(branched), C20-(branched) and C24-(branched)-alkanes

Test animals / tissue source

Species:
rabbit
Strain:
other: Kleine weiße Russen, Chbb-SPF
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Weight at study initiation: 2.1 - 2.3 kg
- Housing: single housing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1 °C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 cm3
Duration of treatment / exposure:
- exposure: 72 h
Observation period (in vivo):
up to 6 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with physiological NaCl solution
- Time after start of exposure: 72 hours after application


SCORING SYSTEM: scoring system according to Draize


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
AVERAGE SCORE 1 h/24 h/48 h/72 h/ 6 days
- Cornea: 0.0/0.0/0.0/0.0/0.0
- Iris: 0.0/0.0/0.0/0.0/0.0
- Conjunctiva: 1.0/0.0/0.0/0.0/0.0
Descripton of effects: redness of conjunctiva in all 3 animals 1 hour after application

Any other information on results incl. tables

In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.

During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were

observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance showed very slight signs of irritation shortly after application of the test substance only, which did not meet GHS criteria. Thus, according to Regulation (EC) 1272/2008 the data are conclusive but not sufficient for classification.
Executive summary:

In an eye irritation study 0.1 cm3 of Tetrabutan (dest.) was instilled into the conjunctival sac of the right eye of 3 rabbits (Kleine weiße Russen, Chbb-SPF, Dr. Karl Thomae GmbH, Biberach). Animals were then observed for 6 days. Irritation was scored by the Draize scheme, according guideline OECD 405.

During the observation period the animals showed redness of the conjunctivae only 1 hour after application. No other symptoms were observed. In this study, Tetrabutan (dest.) is not irritating to eyes based on the mean values of ocular reactions at 24, 48, and 72 hours.