Dimethyl 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: The study was conducted according to OCED TG 405 under GLP conditions and is fully sufficient for endpoint evaluation.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Reference 2

Reference Type:

secondary source

Title:

No information

Author:

ECB-IUCLID

Year:

2000

Bibliographic source:

European Chemicals Bureau, 11-FEB-2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dimethyl phthalate

EC Number:

205-011-6

EC Name:

Dimethyl phthalate

Cas Number:

131-11-3

Molecular formula:

C10H10O4

IUPAC Name:

1,2-dimethyl benzene-1,2-dicarboxylate

Test material form:

liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): Dimethyl phthtalate
- Physical state: no data
- Analytical purity: no data
- Purity test date: no data
- Lot/batch No.: Lab. Jo 16969
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Breeder: Gaukler, D-6050 Offenbach/Main
- Age at study initiation: not reported
- Weight at study initiation: mean M 3.04 kg; mean F 2.60 kg
- Housing: cages made of stainless steel with wire mesh ealk floors, floor area 40 x 51 cm; fully air conditioned rooms
- Diet: about 130g per animal per day, Kliba 341, 4mm (Klingenthalmühle AG, Ch-4303 Kaiseraugst)
- Water: ad libitum
- Acclimation period: at least 8 days before the beginning of the study


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Air changes (per hr): not reported, room fully air conditioned
- Photoperiod (hrs dark / hrs light): 12/12 (06.00 - 18.00/18.00 - 06.00)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume): 0.1 ml

Duration of treatment / exposure:

72h

Observation period (in vivo):

1h, 24h, 48h, 72h after application

Number of animals or in vitro replicates:

3 (2M/1F)

Details on study design:

Comment: not rinsed
REMOVAL OF TEST SUBSTANCE
- Washing: no washing done

SCORING SYSTEM: according to 83/467/EEC

Results and discussion

In vivo

Results

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24-72h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 72h

Remarks on result:

other: 1 animal with score 2 at 1h, but fully reversible

Any other information on results incl. tables

Table 1: Animal numbers and weights

Animal	1	2	3
Animal No.	0962	0973	0975
Animal weight	3.02	2.06	3.06
Sex	M	F	M

Table 2: Cornea, iris and conjunctiva scores:

Readings	Animal	Cornea		Iris	Conjunctiva
		OP	AR		RED	SW	DI
1h	1	0	0	0	1	0	1
1h	2	0	0	0	2	0	1
1h	3	0	0	0	1	0	0
24h	1	0	0	0	1	0	0
24h	2	0	0	0	0	0	0
24h	3	0	0	0	1	0	0
48h	1	0	0	0	1	0	0
48h	2	0	0	0	0	0	0
48h	3	0	0	0	0	0	0
72h	1	0	0	0	0	0	0
72h	2	0	0	0	0	0	0
72h	3	0	0	0	0	0	0
mean	1	0.0	0.0	0.0	0.7	0.0	0.0
mean	2	0.0	0.0	0.0	0.0	0.0	0.0
mean	3	0.0	0.0	0.0	0.3	0.0	0.0
mean	1-3	0.0	0.0	0.0	0.0	0.0	0.0

Legend:
KEY: 
MA = MALE
FE = FEMALE

SCALE FOR SCORING OCULAR LESIONS:
CHEMOSIS (SW) AND CORNEA (OP) (OPACITY-DEGREE OF DENSITY):
0 = NONE 1  
1 = SLIGHT  
2 = WELL-DEFINED  
3 = SEVERE  
4 VERY SEVERE 

CONJUNCTIVAE REDNESS (RED):  
0 = NORMAL  
1 = SLIGHT  
2 = WELL-DEFINED  
3 = SEVERE  

IRIS: 
0 = NORMAL
1 = CIRCUM-CORNEAL INJECTION
2 = IRITIS 

AREA OF CORNEA INVOLVED (AR): 
1 = > 0;  1/4
2 = >= 1/4;  1/2
3 = >= 1/2;  3/4
4 = >= 3/4

DISCHARGE (DI): 
0 = NORMAL
1 = SLIGHTLY INCREASED
2 = CLEARLY INCREASED
3 = DISTINCTLY INCREASED

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The neat substance is not irritating to the eyes.

Executive summary:

The study was conducted according to OCED TG 405 under GLP conditions. 3 (2M/1F) White vienna rabbits were tested for eye irritation after application of thest substance (1 -24 -48 -72h reading). No irritation or corrosion score was observed for iris and cornea. The 24 -48 -72h irritation score for conjunctiva redness was 0.3, no chemosis was observed. Effects were fully reversible within 72h.

The neat substance is not irritating to the eyes.