Bis(2-ethylhexyl) phthalate

Eye irritation

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

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Bis(2-ethylhexyl) phthalate

EC Number:

204-211-0

EC Name:

Bis(2-ethylhexyl) phthalate

Cas Number:

117-81-7

Molecular formula:

C24H38O4

IUPAC Name:

1,2-bis(2-ethylhexyl) benzene-1,2-dicarboxylate

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

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

other: animals # 1, 2 and 3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

iris score

Basis:

other: animals # 1, 2 and 3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Basis:

other: animals # 1, 2 and 3

Time point:

other: 24, 48, 72h

Score:

0

Max. score:

3

Results 4

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.