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Diss Factsheets

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:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
missing data on animals
Principles of method if other than guideline:
Study was conducted using a method equivalent to OECD Testing Guideline 405 and meets acceptable scientific standards. 0.1mL of the registered substance was instilled in the left eye of six New Zealand White, which were therefore observed for seven days, as all observable adverse effects had disappeared by this time. Observations were recorded and scored according to Draize, which is the scoring system used by EU and OECD methods. As a result, it is considered that the study is providing a sufficient amount of data in order to conclude regarding the eye irritation of the registered substance.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
EC Number:
267-032-7
EC Name:
Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
Cas Number:
67762-73-6
IUPAC Name:
Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized
Test material form:
other: Liquid
Details on test material:
- Name of test material (as cited in study report): EC 267-032-7
- Physical state: a viscous, pale yellow liquid with an unpleasant odor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.6 - 3.1 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
Treated eye held closed for one second following application
Observation period (in vivo):
7 days (it was not considered relevant to pursue the observation as all effects had reversed).
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM: According to J.H. Draize

TOOL USED TO ASSESS SCORE: 2.0 % sodium fluorescein stain

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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Max score of 1 reported at 1 and 4 hours observation
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Max score of 1 reported at 1 and 4 hours observation
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Max score of 1 reported at 1 and 4 hours observation
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Max score of 1 reported at 1 and 4 hours observation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Slight redness observed at 1 hour and 4 hours in all animals and at 24 hours in two animals. Slight discharge appeared in all animals at one hour only. All effects were fully reversible in all animals and fluorescein staining at seven days confirmed the absence of corneal damage in all eyes.
Other effects:
Blinking in all animals after treatment.

Any other information on results incl. tables

See attached background information.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance induced a slight redness in all animals, fully reversible within 24 hours for 4/6 animals and 48 hours for 6/6 animals. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

The test substance was analysed for eye irritation on New Zealand white rabbit eyes using a method similar to OECD Guideline 405. The left eye of the animals was exposed to 0.1 mL of the test substance whilst the right eye was left as a control. Fluorecein staining at seven days showed no corneal damage in any of the test subjects. Slight redness was observed in all animals after exposure but did not last more than a day. All animals also showed slight discharge at one hour only. All effects were reversible within 24 hours for 4/6 animals and 48 hours for the remaining animals. The test substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.