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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-compliant OECD guideline study, available as unpublished report, no restrictions, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Eastman TEG-EH
- Description: Eastman(TM) TEG-EH (Triethylene Glycol Bis (2-EthylHexanoate)) Plasticizer
- Physical state: clear colourless liquid
- Specific gravity: 0,968 (20/20C)
- Analytical purity: 99,1% (ester by GC)
- Impurities (identity and concentrations): see confidential details on test material
- Composition of test material, percentage of components: see confidential details on test material
- Purity test date: 2007-07-11
- Lot/batch No.: TD-7022702
- Expiration date of the lot/batch : not provided (production date = 2007-07-11)
- Storage condition of test material: room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: one per cage
- Diet (e.g. ad libitum): ad libitum (Certified Rabbit diet)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Relative humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continous light (06:00 to 18:00) and twelve hours darkness

IN-LIFE DATES: From: 2007-08-01 To 2007-08-08

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
single 4-hour exposure period
Observation period:
After approximately one hour following removal of the patches and 24, 48 and 72 hours later.
An additional observation was made on Day 7 to assess the reversibility of skin reactions.
Number of animals:
3 male animals
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: 4-hour

SCORING SYSTEM: Draize score

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.7
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.8
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal: 66480 Male
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66480 Male
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66480 Male
Time point:
72 h
Score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66491 Male
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66491 Male
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66491 Male
Time point:
72 h
Score:
0
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66492 Male
Time point:
24 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66492 Male
Time point:
48 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal: 66492 Male
Time point:
72 h
Score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal: 66480 Male
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66480 Male
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66480 Male
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66491 Male
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66491 Male
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66491 Male
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66492 Male
Time point:
24 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66492 Male
Time point:
48 h
Score:
0
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
animal: 66492 Male
Time point:
72 h
Score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
Very slight erythema was noted at all treated skin sites at the 24 and 48-hour observations and at one treated skin site at the 72-hour observation.
Two treated skin sites appeared normal at the 72-hour observation and the remaining treated skin site appeared normal at the 7-day observation.

Any other information on results incl. tables

Individual skin reactions:

Skin reaction

Observation time

Individual Scores – Rabbit Number and sex

Total

66480 Male

66491 Male

66492 Male

Erythema/Eschar formation

1 hour

0

0

0

0

24 hours

1

1

1

3

48 hours

1

1

1

3

72 hours

0

0

1

1

7 days

0

0

0

0

Oedema formation

1 hour

0

0

0

0

24 hours

0

0

0

0

48 hours

0

0

0

0

72 hours

0

0

0

0

7 days

0

0

0

0

Sum of 24 and 72-hour readings (S): 4

Primary Irritation Index (S/6): 4/6 = 0.7

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Draize classification criteria, 1959
Conclusions:
Mild irritant
Executive summary:

A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema. Two treated skin sites appeared normal at the 72-hour observation and the remaining treated skin site appeared normal at the 7-day observation. The test material produced a primary irritation index of 0.7 and was classified as mild irritant to rabbit skin according to Draize classification scheme. No corrosive effects were noted.