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Diss Factsheets

Administrative data

Description of key information

Two GLP-studies conducted according to OECD guidelines 404 and 405, respectively, are available for dipropylene glycol methyl ether acetate. The results of these studies are supported by two non-GLP studies conducted according to the same guidelines.

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
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study was conducted according to GLP and meets OECD and EEC guideline requirements.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited, Duddon Lodge, Tarporley, Cheshire
- Age at study initiation: not specified
- Weight at study initiation: not specified
- Housing: The rabbits were housed individually in aluminium cages with grid floors beneath which were peat moss filled trays
- Diet (e.g. ad libitum): The rabbits were fed Standard Rabbit Diet, supplied by Special Diets Services, 1 Stepfield, Witham Essex, CMB 3AD.
- Water (e.g. ad libitum): Tap water was allowed ad libitum
- Acclimation period: 7 days
- IN-LIFE DATES: From: 28 March 1990 To: 31 March 1990

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were 17º C and 16 º C.
- Humidity (%): Mean relative humidity was 68%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700-1900 h)
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml



Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 h after patch removal
Number of animals:
3 (2 male and one female)
Details on study design:
TEST SITE
- Area of exposure: Dorsal area of the trunk
- % coverage: The test material (0.5 ml) was applied to intact skin on each rabbit under a 2.5 cm × 2.5 cm patch of gauze.
- Type of wrap if used: The patch was covered with Micropore tape and the trunk was loosely bound with Elastoplast Elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of exposure period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material
- Time after start of exposure: 4 h


SCORING SYSTEM: See the attachment- Scoring system.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin reactions were noted following a 4 h semi-occlusive application of T-4388 to rabbit skin.
Other effects:
None
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study it was concluded that T-4388 was non-irritant to rabbit skin.
Executive summary:

The acute dermal irritation potential of a test material, T-4388, a colorless liquid was investigated in New Zealand White rabbits. Two male and one female nulliparous and non-pregnant young adult rabbits were used.

The rabbits were housed individually in aluminium cages and were fed with standard rabbit diet and tap water was allowed ad libitum. Mean environmental maximum and minimum temperatures were 17º C and 16 º C and mean relative humidity was 68%. A 12 h light/dark cycle was in operation. The rabbits were allowed an acclimatisation period of 7 days before test commencement.

The rabbits were uniquely identified within the study by means of an indelible number on the inner surface of the ear. The hair was clipped from the dorsal area of the trunk of each rabbit under a 2.5 cm × 2.5 cm patch of gauze. The patch was then covered with micropore tape and the trunk was loosely bound with Elastoplast Elastic Bandage which remained in position for 4 h. At the end of this period the patches were removed and the skin wiped with water dampened tissues to remove surplus test material.

Skin reactions were assessed 1, 24, 48 and 72 h after patch removal using the OECD recommended scoring system. No skin reactions were noted following a 4 h semi-occlusive application of T-4388 to rabbit skin.

Based on the results of the study it was concluded that T-4388 was non-irritant to rabbit 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
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-study according to OECD guideline 405.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Cheshire Rabbit Farms Limited,Duddon Lodge, Tarporley,Cheshire
- Housing: The rabbits were housed individually in aluminum cages with grid floors beneath which were peat moss filled trays
- Water (. ad libitum): Tap water
- Acclimation period:7 days
- Feed: (. ad libitum) Standard rabbit diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CMB 3AD

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Mean environmental maximum and minimum temperatures were both 17°C
- Humidity (%): Mean relative humidity was 51%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light


IN-LIFE DATES: From: 1990-04-04 To: 1990- 04-09
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
Amount: 0.1ml
Concentration - 100 %



Duration of treatment / exposure:
Single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 ( 2 male and 1 female )
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No


SCORING SYSTEM: See other information on materials and methods


TOOL USED TO ASSESS SCORE: 420/5.5× Panoramic Loupe ( Keeler, U. K. ) and Pen torch (Pifco )
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
Over all animals
Time point:
other: 24, 48 and72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects observed
Irritant / corrosive response data:
Slight conjunctival redness, slight chemosis and a slight discharge were noted in 1 h post instillation. All responses were reversible by 24 h. No corneal and iridial responses were noted.
Other effects:
No signs of systemic intoxication were observed
Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study T-4388 is not irritanting to rabbit eyes. As per EU classification this test material does not need be classified.
Executive summary:

The eye irritation potential of a test material, T-4388 (Colorless liquid) was investigated in New Zealand White rabbits. Two male and one female nulliparous and non-pregnant young adult New Zealand white rabbits were used , which were supplied by Cheshire Rabbit Farms Limited,Duddon Lodge, Tarporley,Cheshire.

                                                                                                                

The rabbits were housed individually in aluminum cages with grid floors beneath which were peat moss filled trays. The rabbits were allowed an acclimatization period of 7 days. Mean environmental maximum and minimum temperatures were both 17°C maintained in rabbit rooms with relative humidity 51% and photoperiod of 12 hrs dark / 12 hrs light.

The rabbit was held firmly but gently and the test material 0.1 ml placed into right eye by gently pulling the lower eyelid away from the eyeball to form a sac into which test material was dropped. The lids were then gently held together for one or two seconds and observed up to 48 hours after instillation for signs of severe irritation. As none were noted, remaining 2 rabbits were treated. The other eye rabbit served as a control. The eyes were examined for irritation by using 420/5.5× Panoramic Loupe ( Keeler, U. K. ) and Pen torch (Pifco ) and ocular reactions were recorded 1, 24, 48, 72 hour after instillation.

Slight conjunctival redness, slight chemosis and a slight discharge were noted in 1 h post instillation. All responses were reversible by 24 h. No corneal and iridial responses were noted.

Based on the results of this study T-4388 is slightly irritating to rabbit eyes but this is quickly reversible. As per EU classification this test material is practically non irritating when tested on rabbit eyes.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin irritation: in the study selected as the key study, there were no signs of edema or erythema at any time point. In the supporting study, there were no signs of edema, and a mean score (24, 48 and 72 hr) of 0.06 for erythema. This reveresed fully during the study.

As such this substance is not considered to be a skin irritant.

Eye irritation: In the Key study there were no signs of irritation (Chemosis, conunctiva, iris, cornea) at any time point (mean scores 0 across 24, 48 and 72 hours). In the supporting study the only positive finding was a mean score of 0.17 (24, 48, 72 hrs) for the conjuctiva. This reversed fully during the study.

As such this substance is not irritating to the eye.


Justification for selection of skin irritation / corrosion endpoint:
OECD guideline GLP study, reliability 1

Justification for selection of eye irritation endpoint:
OECD guideline GLP study, reliability 1

Justification for classification or non-classification

Skin irritation: according to EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC) the mean value of the scores for erythema was 0.056. No edema was observed at any time. According to annex VI of the directive dipropylene glycol methyl ether acetate is not classified as skin irritant.

Eye irritation: according to the annex VI of the council directive 67/548 EEC (amended by directive 83/467 EEC) the average score over all animals for redness of the conjunctiva after 24, 48 and 72 hours was 0.17 and for chemosis 0. No corrosion, no signs of systemic intoxication were observed. According to EEC criteria no labelling for eye irritancy is required.