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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
25 June 1995 - 30 June 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed to GLP and according to appropriate OECD and EC Test Guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-TMP (flakes), Di-Trimethylolpropane
- Physical state: Irregular white crystalline flakes
- Lot/batch No.: 54001-80
- Storage condition of test material: Kept in a tight-fitting container at room temperature in the dark
- Other:Test article characterisation (purtiy, solubility and stability etc.) was the responsibility of the Sponsor.

Test animals / tissue source

Species:
rabbit
Strain:
other: SPF albino
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Mølle-gaard Breeding and Research Centre A/S, Ejby, DK-4623 Lille Skensved.
- Weight at study initiation: 2.4 kg
- Housing: Animals housed individually in PPO/HIPS (Noryl) cages (floor area: 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Pelleted complete rabbit diet "Altromin 2123" from Chr. Petersen, DK-4100 Ringsted. Available ad libitum.
- Water (e.g. ad libitum): Free access to bottles containing domestic quality drinking water acidified with hrdyochloric acid to pH 2.5
- Acclimation period: At least one week.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3ºC.
- Humidity (%): 55±15%.
- Air changes (per hr): 10/hour
- Photoperiod (hrs dark / hrs light):12 hours light / 12 hours darkness.


IN-LIFE DATES: From: 25 June 1995 To: 30 June 1995

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Left eye in each animal was treated with test material; the right eye was untreated and used as the control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1g
Duration of treatment / exposure:
Eye lids held shut for 1 second following instillation of the test material into the eye. Exposure was otherwise instantaneous.
Observation period (in vivo):
Eyes were observed after 1, 24, 48, and 72 hours from exposure. After the initial 24 hour assessment, Fluorescein was instilled, the eyes rinsed with saline solution and the eyes examined again using UV light.
Number of animals or in vitro replicates:
3 female rabbbits.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes rinsed following Fluorescein instillation (24 hours) but no dedicated rinsing performed following test substance exposure.


SCORING SYSTEM: Scoring of irritation was largely consistent with the scheme detailed in OECD test guideline 405. Evaluation of scores was based on The Official Journal of the European Communities, L110A, 1993, teh directive of teh comission 93/21/EEC of April 27, 1993.


TOOL USED TO ASSESS SCORE: Fluorescein used, as detailled previously. Also used was a hand held inspection lamp fitted with white and UV-light and magnifying glass with 2x magnification.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Moderate conjuntival irritation (chemosis, redness, discharge) was observed in all rabbits 1 to 48 hours after exposure. Slight corneal opacity was
seen in all rabbits 1 to 24 hours after exposure and in two rabbits 48 hours after exposure. At 72 hours no abnormalities were observed.

Any other information on results incl. tables

Scores for ocular lesions

Rabbit No. / Weight kg

Effect and severity

1 hr

24 hrs, F

48 hrs, F

72 hrs, F

Individual mean score

7695 / 2.4

Corna opacity, area

1

2, 2

1, 1

0, 0

 

Cornea opacity, degree

1

1

0

0

0.33

Iris

0

1

0

0

0.33

Conjunctiva chemosis

2

2

0

0

0.67

Conjunctiva redness

2

2

2

0

1.33

Conjunctiva discharge

3

0

0

0

 

76977/ 2.4

Corna opacity, area

4

1, 1

1, 1

0, 0

 

Cornea opacity, degree

1

1

1

0

0.67

Iris

0

1

0

0

0.33

Conjunctiva chemosis

3

3

1

0

1.33

Conjunctiva redness

1

2

2

0

1.33

Conjunctiva discharge

2

0

0

0

 

7680 / 2.4

Corna opacity, area

4

1, 1

1, 1

0, 0

 

Cornea opacity, degree

1

1

1

0

0.67

Iris

0

1

0

0

0.33

Conjunctiva chemosis

4

3

1

0

1.33

Conjunctiva redness

2

2

1

0

1.00

Conjunctiva discharge

2

0

0

0

 

 

F: reading after instillation of oculoguttae fluoresceini

Only the scores from the 3 readings (24, 48, and 72 hours) are included in the calculation of the individual mean scores.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study, Di-TMP was found to be a moderate eye irritant but does not require classification as an eye irritant according to the CLP Regulation.
Executive summary:

An eye irritation study was performed to determine the potential for irritation to eyes when 0.1g of the test substance Di-TMP was administered to the left eye of three rabbits. The study was conducted to GLP and according to OECD 405 and EC B5 Test Guidelines. Moderate conjunctival irritation (chemosis, redness, discharge) was observed in all rabbits 1 to 48 hours after exposure. Slight corneal opacity was seen in all rabbits 1 to 24 hours after exposure and in two rabbits 48 hours after exposure. At 72 hours no abnormalities were observed. Under the conditions of this study, Di-TMP was found to be a moderate eye irritant but does not require classification as an eye irritant according to the CLP Regulation.