Registration Dossier
Registration Dossier
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EC number: 274-641-1 | CAS number: 70516-41-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 to 29 March 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken to internationally accepted guidelines but before the implementation of GLP regulations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.42: Test for eye irritants
- Deviations:
- not specified
- GLP compliance:
- not specified
Test material
- Reference substance name:
- S-205
- IUPAC Name:
- S-205
- Details on test material:
- - Name of test material (as cited in study report): S-205
- Physical state: white powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: reputable
- Age at study initiation: 12 to 16 weeks old
- Weight at study initiation: 2.3 to 3.1 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): laboratory animal diet ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: yes but no details
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12 hrs dark / hrs light
IN-LIFE DATES: From: 22 March 1982 To: 29 March 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 50mg of S-205 (corresponding to a volume of 0.1mL)
- Duration of treatment / exposure:
- S-205 was placed into the lower everted lid of one eye of each animal. The eyelids were then gently held together for one second before releasing. The eyes were not washed out.The contralateral eye remained untreated and served as a control.
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): not done
- Time after start of exposure: not applicable
SCORING SYSTEM: "Illustrated Guide for Grading Eye Irritation Caused by Hazardous Substances", Directorate for Engineering and Science.
u.S. Consumer Product Safety Commission, Washington D.C. 20207.
TOOL USED TO ASSESS SCORE: a handheld torch
Results and discussion
In vivo
- Irritant / corrosive response data:
- Mild inflammation or a diffuse crimson-red colouration of the conjunctivae was seen in three rabbits. The eyes of two of these rabbits were normal by Day 2 and that of the third by Day 4. No ocular reactions were recorded in the remaining three rabbits.
Any other information on results incl. tables
Rabbit Number and sex
|
Region of the eye
|
Day after instillation |
|||||
1 |
2 |
3 |
4 |
7 |
|||
2744 F
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
2 |
1 |
1 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
2763M
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
2765F
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
2766F
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Contjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
2767M
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
0 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
2768F
|
Cornea |
0 |
0 |
0 |
0 |
0 |
|
Iris |
0 |
0 |
0 |
0 |
0 |
||
Conjunctivae |
Redness |
1 |
0 |
0 |
0 |
0 |
|
|
Chemosis |
0 |
0 |
0 |
0 |
0 |
|
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The eye irritation test for S-205 was negative
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