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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:
09.08.1981 to 29.09.1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
Method: other (no further details)
GLP compliance:
no
Remarks:
Major elements of GLP were followed. The report was audited, and signed by Quality Assurance.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckshire Corporation, PA.
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually in suspended stainless steel wire mesh cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±2
- Humidity (%): 50±5
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 09.08.1981 to 29.09.1981

Test system

Vehicle:
other: some applications diluted with water
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): some applications were 5% solution.
Duration of treatment / exposure:
The eyes of three of the animals were washed 20 seconds after instillation.
Observation period (in vivo):
21 days.
Number of animals or in vitro replicates:
18
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, in six of 18 animals.
- Time after start of exposure: 20 seconds.


SCORING SYSTEM: Draize.

TOOL USED TO ASSESS SCORE: Fluorescein, slit-lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
11.8
Max. score:
110
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
10.5
Max. score:
110
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
6.3
Max. score:
110
Irritant / corrosive response data:
In unwashed eyes treated with undiluted test substance, blinking and tearing were observed in all eyes within minutes after instillation. Pannus of the cornea developed in 2 of the 6 animals. Corneal opacities, covering a minimal area of the cornea, persisted for 21 days (termination of study) in the animals which developed pannus. Conjunctival redness was also observed in several test eyes. In the washed eyes, treated with undiluted test material and washed 20 seconds later, minimal signs of irritation reported. No irritation was observed in the washed and unwashed eyes of rabbits exposed to 5% of the test material in water.

Any other information on results incl. tables

Table 1 Summary of results for undiluted test substance
 Treatment  Observation intervals (days) post-exposure                     
   1  2  3  4  7  10  13  21
 Unwashed (6 rabbits)  11.8  10.5  6.3  6.0  3.0  2.3  2.0  2.0
 Washed (3 rabbits)  1.3  1.3 0.6   0  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In an eye irritation study (reliability score 2) conducted using a protocol similar to OECD 405 (with additional elements), and although not strictly to GLP, the study was audited and signed by Quality Assurance, TMSPGE was irritating to the eyes of rabbits. Effects were not fully resolved at the end of the 21-day observation period.
Executive summary:

In an eye irritation study (reliability score 2) conducted using a protocol similar to OECD 405 (with additional elements), and although not strictly to GLP, the study was audited and signed by Quality Assurance, TMSPGE was irritating to the eyes of rabbits.