Registration Dossier

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
Study period:
1997/10/17-1998/03/02
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Development Detergent Alcohol 23731-52. Equivalent to Alcohols, C16-17, monobranched, type 2

- Substance type:

- Physical state: Clear, colourless liquid

- Analytical purity: The purity of the test material is the responsibility of the sponsor.

- Storage condition of test material: Stored under nitrogen in the original container at room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS

- Source: Covance Research Products, Inc., Denver, PA

- Age at study initiation: Young adults.

- Weight at study initiation: 3686 - 3790g

- Housing: Individual suspended wire mesh cages.

- Diet: PMI Feeds, Inc. Certified Rabbit LabDiet 5322, at ca. 150 g per day during the study

- Water: Reverse osmosis treated municipal water (ad libitum)

- Acclimation period: minimum of 5 days


ENVIRONMENTAL CONDITIONS

- Temperature (°F): 66.1-67.6

- Humidity (%): 41.7-45.2%

- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye.
Amount / concentration applied:
TEST MATERIAL

- Amount(s) applied (volume or weight with unit): 0.1ml/right eye
Duration of treatment / exposure:
A single unwashed exposure.
Observation period (in vivo):
The eyes were examined for ocular lesions at 1, 24, 48, 72 hours after dosing and on days 4 and 7 if irritation persisted.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE

- Washing (if done): no washing



SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.67
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24/48/72h
Score:
0.33
Max. score:
1
Irritant / corrosive response data:
There were no deaths during the study.
Other effects:
Minor conjunctival irritation was observed for all rabbits. There were no corneal or iridal findings. All irritation was reversible and completely subsided by day 7.

Any other information on results incl. tables

Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test

Score at time point / Reversibility

Cornea

Iris

Conjunctivae

Chemosis

Max. score: 4

Max. score: 2

Max. score: 3

Max. score: 4

60 min

0/0/0

0/0/0

 1/1/1

 1/1/0

24 h

 0/0/0

 0/0/0

 1/1/1

 0/1/1

48 h

 0/0/0

 0/0/0

 0/1/1

 0/1/1

72 h

 0/0/0

 0/0/0

 0/0/1

 0/0/1

Average 24h, 48h, 72h

 0

 0

 0.67

 0.33

Reversibility*)

 -

Average time (unit) for reversion

 

 

Day 7 

Day 7

 *) Reversibility: c. = completely reversible; n.c. = not completely reversible; n. = not reversible

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The Maximum Average Score for Fevelopment Detergent Alcohol 23731-52 was 3.3 at one and 24 hours post instillation. This was determined in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP.