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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
DEHP
- Name: Vestinol AH
- Purity >99%
- Physical state: clear liquid
- Batch n°: 963
- Storage: in refrigerator, in dark, protected from air and humidity

Test animals / tissue source

Species:
rabbit
Strain:
other: Little White Russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach
- Age at study initiation: no data
- Weight at study initiation: 2.0-2.3 kg
- Housing: individually
- Diet (e.g. ad libitum): ad libitum K4 diet for rabbits, Ssniff Spzialdiät GmbH, 4770 Soest
- Water (e.g. ad libitum): ad libitum tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20+/-1
- Humidity (%): 60+/-5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye
Amount / concentration applied:
0.1ml of the undiluted DEHPwas administered in the right eye. Left eye was remained untreated and served as control.
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
6 d
Number of animals or in vitro replicates:
3 males
Details on study design:
The animals were evaluated after 1, 24, 48, and 72 hours, and after 6 days of application, using the grading system of the OECD guideline.

At 72hours, fluorescein was used for evaluation of corneal damages. The eyes was then rinsed with warm NaCl

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: animals # 1, 2 and 3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
other: animals # 1, 2 and 3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
other: animals # 1, 2 and 3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
other: animals # 1, 2 and 3
Time point:
other: 24, 48, 72h
Score:
0
Max. score:
4
Irritant / corrosive response data:
At 1 hour, the conjunctivae of all three rabbits showed mild redness and one rabbit showed mild discharge.
No conjunctival reactions were observed at the later observation times.
All observations for chemosis, corneal opacity and lesions of the iris were negative.

Any other information on results incl. tables

Corneal score   1h 24h 48h 72h+6d
Rabbit N° Sex A B AxBx5 A B AxBx5 A B AxBx5 A B AxBx5
38133 M 0 0 0 0 0 0 0 0 0 0 0 0
38323 M 0 0 0 0 0 0 0 0 0 0 0 0
38457 M 0 0 0 0 0 0 0 0 0 0 0 0
Mean     0   0   0   0

A=Opacity

B=Area of opacity

Iris score   1h 24h 48h 72h+6d
Rabbit N° Sex A A x 5 A A x 5 A A x 5 A A x 5
38133 M 0 0 0 0 0 0 0 0
38323 M 0 0 0 0 0 0 0 0
38457 M 0 0 0 0 0 0 0 0
Mean     0   0   0   0

A=Modification

Conjunctival score   1h 24h 48h 72h+6d
Rabbit N° Sex A B C (A+B+C)x2 A B C (A+B+C)x2 A B C (A+B+C)x2 A B C (A+B+C)x2
38133 M 1 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0
38323 M 1 0 1 4 0 0 0 0 0 0 0 0 0 0 0 0
38457 M 1 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0
Mean     2,67   0   0   0

A=redness

B=oedema

C=exsudation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 December 2008
Executive summary:

In a study performed in accordance with OECD guideline 405, eye irritation of DEHP (>99% pure) was studied. DEHP in a volume of 0.1 ml was installed in the right eye of three male Little White Russian rabbits. The left eye served as control. The animals were evaluated after 1, 24, 48, and 72 hours, and after 6 days of application, using the grading system of the OECD guideline.

At 1 hour, the conjunctivae of all three rabbits showed mild redness and one rabbit showed mild discharge. No conjunctival reactions were observed at the later observation times. All observations for chemosis, corneal opacity and lesions of the iris were negative.

DEHP was considered as non-irritant for the eye.

Mean irritation scores calculated for times 24, 48 and 72h of the animals 1, 2, 3 were 0, 0, 0 for cornea, 0, 0, 0 for iris, 0, 0, 0 for conjunctiva and 0, 0, 0 for chemosis, respecitvely.