Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to current guideline and in compliance with GLP. The study is read across from 1-decanol (CAS 112-30-1).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Principles of method if other than guideline:
The humidity was above the targeted upper limit of 70% during the study due to exceptionally high seasonal humidity. Portable dehumidifiers were ised to lower the humidity levels during this time.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Alfol 10

- Physical state: colourless liquid, sweet pungent odour

- Storage condition of test material: room temperature
- Other:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Robinson Services Inc., Clemmons
- Age at study initiation: young adult
- Weight at study initiation:
- Housing:suspended stainless steel caging with mesh floors
- Diet: Pelleted purina rabbit chow, ad libitum
- Water: filtered tap water, ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21
- Humidity (%): 59-81
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
single instillation, not washed
Observation period (in vivo):
Occular irritation was evaluated at 1, 24, 48 and 72 hours and at 4 and 7 days post-instillation.
Number of animals or in vitro replicates:
3F
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 24 hours
Score:
28.3
Irritant / corrosive response data:
Within one hour of test substance instillation, all three treated eyes exhibited corneal opacity, iritis and 'positive' conjunctivitis with the maximum effect observed at 24 hours. The overall incidence and severity of irritation decreased after 24 hours. All animals were free of ocular irritation by day 7 (study termination).
Other effects:
None reported.

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

1/1/1

1/1/ 1

 2/2/2

2/ 2/2

24 h

 1/1/1

 1/1/1

 3/3/2

 2/2/2

48 h

 1/1/1

 1/1/1

 2/2/2

 1/1/1

72 h

 0/0/0

 1/0/0

 2/1/1

 1/1/0

Reversibility*)

 c

Average time (unit) for reversion

 72h

72h

Day 7

Day 7

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

 

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: US EPA
Conclusions:
The maximum mean score of 28.3 at 24 hours was reported in a high relaibility study, conducted according to an appropriate guideline and in compliance with GLP.