Dimethyl phthalate

Endpoint summary

Description of key information

DMP is not irritating to skin and eyes. No data are available for the respiratory system.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study is reliable with restrictions due to limited reporting (non-GLP study). Basic data are given and study is sufficient for endpoint evaluation.

Principles of method if other than guideline:

Method: historical Method according to Draize et al. (1944). See any further information on materials and methods for details.

GLP compliance:

no

Specific details on test material used for the study:

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

Species:

rabbit

Strain:

other: only mentioned: albino rabbit

Details on test animals or test system and environmental conditions:

no details reported

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml neat test substance; density =1.194 g/ml

Duration of treatment / exposure:

24 h

Observation period:

24-72h reading

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: patch size 2.5 x 2.5cm, four patches are placed at the back of the animal, 10cm apart
- Type of wrap if used: rubberized cloth, wrapping the whole animal trunk

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
- Time after start of exposure: 24h patch exposure

SCORING SYSTEM: "the primary irritation index" according to Draize etal. (1948)

Irritation parameter:

overall irritation score

Remarks:

skin

Basis:

mean

Time point:

other: 24-72h combined average

Score:

0.7

Reversibility:

other: no substance-related effects

Remarks on result:

other: combined average is based on averages from intact and abraded rabbit skin

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance did not cause skin irritation but irritation of mucous membrane.
The test substance is not irritating to the skin.

Executive summary:

The study was conducted according to the method described by Draize et al. (1944) and is reliable with acceptable restrictions. Restrictions are due to limited reporting in times befor GLP. Skin irritation was tested in albino rabbits in vivo. Neat test substance (0.5ml unchanged, no vehicle) was applied on abraded and intact skin (occlusive) for 24h (reading 24 -72h).

The test substance is not irritating to the skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

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.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

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

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)

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation:

DMP was tested according to a method described by Draize et al. [1944] and is reliable with acceptable restrictions. Skin irritation was tested in albino rabbits. Neat test substance (0.5 ml unchanged, no vehicle) was applied on abraded and intact skin (occlusive) for 24 h (reading 24 -72 h). Readings were also performed after 72 hours and the final score represents, an average of the 24- and 72-hour readings. The combined average is referred to as "the primary irritation index" and is useful for placing compounds in general groups with reference to their irritant properties. The overall irritation score was 0.7 (24 -72h combined average), no irritation of the skin was observed. There is also human evidence as reported by BASF test [BASF AG, unpublished report, 1948] where DMP did not cause irritation in a patch test, and another study [Frosch et al., 1977] reported no irritation in a ”stinging assay”.

Eye irritation:

DMP was tested for eye irritation according to OCED TG 405 under GLP conditions in an BASF study [study No. 11H0540/902146, 1990]. Three (2M/1F) White rabbits were tested for eye irritation after application of test substance, reading was done after 1 -24 -48 -72 h according to the Draize scoring system. No irritation or corrosion score was observed for iris and cornea. The 24 -48 -72 h irritation score for conjunctiva redness was 0.3, no chemosis was observed. All effects were fully reversible within 72h. Therefor, DMP is considered to be not irritating to the eyes. Lawrence et al. [1975] also reported that DMP causes no eye irritation in rabbit.

However, there are some findings on eye irritation in a test described by Draize et al. [1944] in rabbits. But irritation is assessed only after 1 and 24 h in this study, reversibility is not examined. Carpenter and Smyth [1946] reported weak irritation (2/10 points) based on their own scoring system using 0.5 ml neat substance. It must be mentioned that the OECD TG 405 on “acute eye irritation and corrosion” recommends 0.1 ml at maximum.

Respiratory irritation:

There are no data available for respiratory irritation.

Conclusion:

The test substance did not cause skin or eye irritation.

Justification for classification or non-classification

GHS classification (GHS UN rev.2, 2007):

- Skin corrosion/irritation: no classification required

- Serious eye damage/eye irritation: no classification required