Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09/07/1984-16/07/1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: OS#63466G
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: not specified

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Ace Animals Inc, Boyertown (PA), USA
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: yes (duration not specified)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18.3-23-9°C (65-75°F)
- Humidity (%): 45-55
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 9/07/1984 To: 16/07/1984

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 g
Duration of treatment / exposure:
Single exposure
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE: No

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
4.7
Max. score:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 48 hours
Score:
3.3
Max. score:
1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 hours
Score:
3.3
Max. score:
2
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 96 hours
Score:
2.7
Max. score:
1
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 7 days
Score:
2
Max. score:
1

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, ATBS was irritating to eyes.