Registration Dossier

Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1992
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions, read-across substance

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester
EC Number:
944-989-5
Molecular formula:
C42H80O7 - C45H86O7
IUPAC Name:
1,2,3-Propanetricarboxylic acid, 2-Hydroxy-, tris(C12-13-branched-alkyl)ester
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona Comense (NO), Italy
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: singly in stainless steel cages (dimensions: 450x500x380 mm)
- Diet: standard pellet complete diet ad libitum supplied by the authorized breeder RIEPER
- Water: filtered tap water from local network ad libitum
- Acclimation period: one week

ENVIRONMENTAL CONDITIONS
Temperature and humidity were regulated by a conditioning plant and were continuously recorded, no further details mentioned
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 02-JUN-1992 To: 09-JUN-1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
at 1, 24, 48 and 72 hours and after 7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not washed

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: no data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: 60 min
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 d
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
for details see table below

Any other information on results incl. tables

Table: 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

 0/0/0/0/0/0

1/1/1/1/1/1

 0/0/0/0/0/0

24 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/1/1/0/0

 0/0/0/0/0/0

48 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/1/1/0/0

 0/0/0/0/0/0

72 h

 0/0/0/0/0/0

 0/0/0/0/0/0

 0/0/1/1/0/0

 0/0/0/0/0/0

Average 24h, 48h, 72h

 0

 0

 0.33

 0

Reversibility*)

 -

 -

 c.

 -

Average time for reversion

 -

 -

 7 d

 -

 

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

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was not an eye irritant.
Executive summary:

An ocular irritation test was carried out on test material Cosmacol ECI according to OECD Guideline 405.

The test was performed by placing the test material in a single dose in the conjunctival sac of 6 albino male rabbits at a dose of 0.1 mL/animal. The animals eyes were examined 1, 24, 48 and 72 hours after the beginning of the test. The ocular areas obvserved were the cornea, the iris and conjunctivae. The results showed a slight congestion of the conjunctivae in all 6 rabbits 1 h and in 2 of 6 animals 24, 48, 72 h

after the treatment. After 7 days it disappeared.

It was concluded that the read-across substance Cosmacol ECI is to be considered non-irritant to eyes.