Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
7 dagen
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Although the study was old and not performed under GLP conditions, the described study method was comparable to OECD Guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
not under GLP conditions (studies dates 1983)
Principles of method if other than guideline:
Six animals are dived per two and were treated as follows:
Group 1- the test substance is added and not rinsed.
Group 2- the test substance is rinsed after 4 seconds with 0.5% alcohol.
Group 3- the test substance is rinsed after 8 seconds with 0.5% alcohol.

In all treated animals the other eye serves as negative control. Irritation is scored after 24, 48, 72 hours, and after 4 and 7 days conform Draize.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
-Name of test material (as cited in study report): ZOR-F
- Substance type: white to off-white powder
- Physical state: solid
- Analytical purity: 98.6 %
- Impurities (identity and concentrations): no impurities -> 1%
- Purity test date: not mentioned
- Lot/batch No.: 28055
- Expiration date of the lot/batch: not mentioned
- Storage: ambient temperature
- Other: a Certificate of Analysis of batch 28055 is included in the report

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Broekman te Someren
- Age at study initiation: not mentioned
- Weight at study initiation: 2,2 - 3,2 kg
- Housing: not mentiond
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not mentioned

ENVIRONMENTAL CONDITIONS: not mentioned

Test system

Vehicle:
not specified
Controls:
other: other eye served as negative control
Amount / concentration applied:
TEST MATERIAL: not mentioned

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.4 g
Duration of treatment / exposure:
Rinsed after 4 and 8 seconds, or not rinsed.
Observation period (in vivo):
24, 48, 72 hours, and 4 and 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 and 8 seconds, or not

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 2, 3, 4, 7 days
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 2, 3, 4, 7 days
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Time point:
other: 1, 2, 3 ,4, 7 days
Score:
0
Max. score:
0
Irritant / corrosive response data:
not irritant, not corrosive
Other effects:
none

Any other information on results incl. tables

none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
A study in 6 rabbits revealed that ZOR-F was not irritating for the eye. The study was not performed under GLP conditions, but the used method was comparable to OECD Guideline 405.