Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restrictions (7-day observation period; purity not specified; non GLP)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
7-day observation period
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: brown powder
No additional details provided

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Porton strain bred on the premises
- Age at study initiation: 10-12 weeks
- Weight at study initiation: ca. 2.23 kg for males and 2.55 kg for females
- Housing: caged singly in an experimental room
- Diet (e.g. ad libitum): commercial irradiated diet (Styles-Oxoid); ad libitum
- Water (e.g. ad libitum): sterile filtered drinking water; ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70%
- Photoperiod (hrs dark / hrs light): 10/14

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
continuously (3 animals without rinsing) or 30 second (3 animals with rinsing)
Observation period (in vivo):
up to 7 days
Number of animals or in vitro replicates:
3 without rinsing and 3 with rinsing
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eyes of 3 rabbits were each rinsed with 10 ml lukewarm water for 1 min (only the rabbits without washing are further considered for assessment, because they are closer to the guideline conditions)
- Time after start of exposure: about 30 seconds after treatment

SCORING SYSTEM: comparable to the OECD scoring system after 1, 6, 24, 48, and 72 hours, and after 7 days.

TOOL USED TO ASSESS SCORE: hand-slit lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0.11
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Remarks on result:
other: redness score of 1 was observed in one animal after 24 hours, but was completely reversible within 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24-48-72-hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
Only chemosis (in all 3 animals without washing; scores 2, 2 and 1, respectively after 1 hours) and conjunctivae redness (in 2/3 animals after 1 hour [scores, each 1]; in 3/3 animals after 6 hours [1, 2 and 1 respectively]; and in 1/3 animals after 24 hours [1]) were observed, but were fully reversible within 6 and 48 hours, respectively. It therefore can be assumed that the test substance is not irritating to the rabbit eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information