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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:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No details on test substance, animals and environmental conditions.
Principles of method if other than guideline:
Method: other: Insufficient detail to fully assess comparability with OECD guideline.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
100 mg of a finely ground powder placed into the conjunctival sac of the right eye.
Duration of treatment / exposure:
24 hour(s)
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Three
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm isotonic saline solution.
- Time after start of exposure: 24 hours.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Results
Irritation parameter:
other: Average maximum score
Basis:
mean
Time point:
other: 24 hours
Score:
53.6
Max. score:
110
Reversibility:
not fully reversible within: Seven days
Remarks on result:
other: Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.
Irritant / corrosive response data:
Oedema with the lids about half closed, copious discharge, moderate redness of the conjunctivae and mild corneal cloudiness were recorded by one hour after instillation. The lids were nearly closed overnight and there was moderate iris conjunction (24 hours). Improvement followed irrigation so that within five days iris clarity was nearly normal in two animals. Also, discharge had ceased and oedema had reduced considerably.
Other effects:
Signs of discomfort or pain were pawing at the eyes.

Any other information on results incl. tables

Table 1 Summary of eye irritation scores

 Animal Number                 Numerical Evaluation* at the end of:
   1 hour  24 hours  48 hours  72 hours  120 hours  168 hours
 1 - Male  32  57  48  39  19  8
 2 - Female  25  49  41  31  10  2
 3 - Male  27  55  44  29  8  2
 Average  28.0  53.6  44.3  33.0  12.3  4.0

*Results given as one overall score per animal, not broken down into effects on cornea/iris/conjunctivae.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In a summary of an eye irritation study (reliability score 2) conducted prior to the adoption of OECD test guidelines and GLP, finely ground powder of ATMP-H (Dequest 2000) caused moderately severe eye irritation to rabbit eyes.
Executive summary:

In an eye irritation study conducted prior to the adoption of OECD test guidelines and GLP, 100 mg of a finely ground powder of ATMP-H was placed in the conjunctival sac of the right eye of each of three albino rabbits. The eyes were rinsed with warm isotonic saline solution after 24 hours. The eyes were then observed and reactions scored for seven days. Following instillation, animals showed signs of discomfort/pain. Oedema with the lids about half closed, copious discharge, moderate redness of the conjunctivae and mild corneal cloudiness were recorded by one hour after instillation. The lids were nearly closed overnight and there was moderate iris conjection (24 hours). Improvement followed irrigation so that within five days iris clarity was nearly normal in two animals. Also, discharge had ceased and oedema had reduced considerably. The average maximum score was 53.6 out of a possible 110, at 24 hours post-exposure (individual scores for cornea, iris and conjunctivae not given in study report). It was concluded that ATMP-H is a moderately severe eye irritant.