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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
other: Study predates GLP and lacks information on exposure conditions and purity of test substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Nine male albino rabbits of the New Zealand Strain were incorporated in this study. A dosage of 100 mg of DM-8122 was introduced into the conjunctival sac of the right eye of each rabbit; the left eye served as an untreated control. Three of the rabbit eyes were rinsed with approximately 20 ml of luke warm water two seconds after instillation of the test material, and three of the rabbit eyes were washed similarly four seconds after instillation of the test compound. The remaining three treated eyes were left unwashed.

The nine treated rabbit eyes were scored against the corresponding untreated control eyes according to the method of Draize (Draize, J. H., in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Assoc. of Food and Drug Officials of U.. S., Austin, Texas, 1956) at 24, 48 and 72 hours after instillation of DM-8122.

GLP compliance:
no
Remarks:
Pre-dates GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
Dibutyltin dichloride
EC Number:
211-670-0
EC Name:
Dibutyltin dichloride
Cas Number:
683-18-1
Molecular formula:
C8H18Cl2Sn
IUPAC Name:
dibutyltin dichloride

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
No data regarding test animals and environmental conditions was reported.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
A dosage of 100 mg of the test material was introduced into the conjunctival sac of the right eye of each rabbit; the left eye served as an untreated control. Three of the rabbit eyes were rinsed with approximately 20 ml of luke-warm water two seconds after instillation of the test material, and three of the rabbit eyes were washed similarly four seconds after instillation of the test compound. The remaining three treated eyes were left unwashed.
Observation period (in vivo):
24, 48 and 72 hour intervals
Number of animals or in vitro replicates:
9 male rabbits (3 for each group)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Three of the rabbit eyes were rinsed with approximately 20 ml of luke-warm water two seconds after instillation of the test material, and three of the rabbit eyes were washed similarly four seconds after instillation of the test compound. The remaining three treated eyes were left unwashed.


SCORING SYSTEM:
Draize

Results and discussion

In vivo

Results
Irritation parameter:
other: Draize score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
110
Reversibility:
not specified
Irritant / corrosive response data:
The group mean score at 24 hours was 110/110. The group mean scores at 48 and 72 hours were 110/110. The Draize evaluation does not provide for the observation of hemorrhage which was noted in this test. The test material would be considered a severe irritant to the eye.
Other effects:
One rabbit from each group was selected for autopsy following the 72-hour reading. Complete enucleation of the eye was noted in each animal examined.

Any other information on results incl. tables

Results:

 

 No rinse 2 seconds and rinsed 4 seconds and rinsed
Rabbit 1 Rabbit 2 Rabbit 3 Rabbit 4 Rabbit 5 Rabbit 6 Rabbit 7 Rabbit 8 Rabbit 9
24 hours Cornea                  
Opacity 4 4 4 4 4 4 4 4 4
Area Involved 4 4 4 4 4 4 4 4 4
Iris                  
Evaluation 2 2 2 2 2 2 2 2 2
                   
Conjunctivea                  
Hyperemia 3 3 3 3 3 3 3 3 3
Chemosis 4 4 4 4 4 4 4 4 4
Discharge 3 3 3 3 3 3 3 3 3
Total Score   110 110 110 110 110 110 110 110 110
48 hours Cornea                  
Opacity 4 4 4 4 4 4 4 4 4
Area Involved 4 4 4 4 4 4 4 4 4
Iris                  
Evaluation 2 2 2 2 2 2 2 2 2
                   
Conjunctivea                  
Hyperemia 3 3 3 3 3 3 3 3 3
Chemosis 4 4 4 4 4 4 4 4 4
Discharge 3 3 3 3 3 3 3 3 3
Total Score   110 110 110 110 110 110 110 110 110
72 hours Cornea                  
Opacity 4 4 4 4 4 4 4 4 4
Area Involved 4 4 4 4 4 4 4 4 4
Iris                  
Evaluation 2 2 2 2 2 2 2 2 2
                   
Conjunctivea                  
Hyperemia 3 3 3 3 3 3 3 3 3
Chemosis 4 4 4 4 4 4 4 4 4
Discharge 3 3 3 3 3 3 3 3 3
Total Score   110 110 110 110 110 110 110 110 110

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize method
Conclusions:
According to the Draize evaluation, the test material would be considered a severe irritant to the eye.
Executive summary:

In a primary eye irritation study in rabbits (AME contract number: 120-697-12-70) the test material was considered a severe irritant to the eye.

The scoring was conducted according to the Draize method. The Draize evaluation does not provide for the observation of hemorrhage which was noted in this test.

One rabbit from each group was selected for autopsy following the 72-hour reading. Complete enucleation of the eye was noted in each animal examined.