Registration Dossier

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:
From 21 September 1987 to 23 December 1987
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Non GLP compliant study, method according to OECD TG 405. Sufficient information but no more details on the method in the report

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
No certificate of analysis was provided, no details on the method was given but the report is sufficient for assessment
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: not specified
- Expiration date of the lot/batch: not provided in the present report
- Purity test date: not provided in the present report

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: not specified
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Age at study initiation: not specified
- Weight at study initiation: 3.38 kg for male and 3.07 kg for female
- Housing:cage made of stainless steel with wire mesh walk floors (40x51cm for floor area)
- Diet (e.g. ad libitum): Kliba 341.4 mm about 130g per animal per day
- Water (e.g. ad libitum): 250 mL tap water per day per animal
- Acclimation period: at least 8 days before the beginning of the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70% relative humidity
- Air changes (per hr): fully air-conditioned room
- Photoperiod (hrs dark / hrs light): 12 hours / 12 hours (6:00 to 18:00 light period)

IN-LIFE DATES: From: Not specified : To : 2 September 1987

Test system

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

VEHICLE
Not applicable
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
8 Days
Number of animals or in vitro replicates:
3 animals were used
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing was performed
- Time after start of exposure: not applicable

SCORING SYSTEM: Calculation of the mean according to 83/467/EEC criteria of July 29th 1983

TOOL USED TO ASSESS SCORE: not detailed

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
fully reversible within: 8 Days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 8 days
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
not specified
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible

Any other information on results incl. tables

Table 1 :Results

Cornea

 

IRIS

Conjunctivae

 

 

Symptoms

Readings

Animal

OP

AR

IRIS

Red

SW

Di

 

1hours

1

0

0

0

2

0

1

 

 

2

0

0

0

2

0

0

 

 

3

0

0

0

2

1

0

 

24hours

1

0

0

0

2

0

0

 

 

2

0

0

0

2

0

0

 

 

3

0

0

0

2

0

0

 

48hours

1

0

0

0

2

0

0

 

 

2

0

0

0

2

0

0

 

 

3

0

0

0

2

0

0

 

72hours

1

0

0

0

2

0

0

 

 

2

0

0

0

2

0

0

S

 

3

0

0

0

3

0

0

 

8days

1

0

0

0

0

0

0

 

 

2

0

0

0

0

0

0

LH

 

3

0

0

0

0

0

0

 

Mean

1

0

 

0

2

0

 

2

0

 

0

2

0

 

3

0

 

0

2.3

0

Mean

1, 2 and 3

0

 

0

2.1

0

 

Scale for scoring ocularlesions :

Chemosis (SW) and Cornea (OP)

0 : None

1: Very slight

2: Well defined

3: severe

4: very severe

 

Area of cornea involved (AR)

1= >0 ;<1/4

2= >= 1/4 ;<1/2

3= >=1/2 ;<3/4

4= >= ¾

Conjunctivae redness (Red):

0 : None

1: Very slight

2: Well defined

3: severe

Discharge (DI):

0 : Normal

1: Slightly increased

2: Clearly increased

3: Distinctly increased

Iris

0=Normal

1=Circum-Corneal injection

2=irititis

Explanation of symptoms

LH : Loss of hair

S : SUppuration

 

 

Explanation of symptoms:

S02: Superficial scurf

ED:E:Edemea, Extending beyond the area of exposure

R:E: Erythema, Extending beyond the area of exposure

S:E,E: Scaling, severe, Extending beyond the area of exposure

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Based on the results of the study, the trihexylamine induced conjunctival redness which is reversible after 8 days (mean score 24//48/72 hours = 2.1). Hence, according to CLP criteria, the test item was considered as Irritant for eyes Category 2.
Executive summary:

This non-GLP compliant study was assessed to evluate the eye irritation potentiel of the registered item tri-N-hexylamine. This study follows the OECD TG 405 method.

Vienna White rabbits were used in this study. They were treated with 0.1 mL of unchanged test item in tight eye (single application to the conjunctival sac of the right eyelid). Readings for ocular lesions were performed at 1 hours, 24 hours, 48 hours, 72 hours and 8 days after treatment.

The test item induced irritation (redness) to rabbit eye when applied. This adverse effect was reversible until the day 8 of observation.

Based on the results of this study, the trihexylamine induced eye irritation when applied on rabbit eye. This adverse effect was reversible up to 8 days after exposure. According to CLP regulation, the test item trihexylamine was classified as Category 2 for eye irritation.