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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:
1995-03-07 to 1995-03-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
17 July 1992
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: Partie 24, 05-Jan-1995; Product number / code: LP 1941
- Substance type: Borated Glycol Ether
- Expiration date of the lot/batch: stable until 05-Jul-1995
- Purity test date: Not provided
- Analytical purity: 97% (calculated after titration of boric acid)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Chemical pharmaceutical factory Dr. K. Thomae, 88400 Biberach, Germany; SPF breed
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.8-3.2 kg
- Housing: separate cages (arranged in a battery), air-conditioned rooms
- Diet: ssniff K-H (V2333) ad libitum and hay (approx. 15 g daily)
- Water: from automatic dispensers ad libitum
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1995-03-07 To 1995-03-10

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 per patch (undiluted)
- Concentration (if solution): 100% (undiluted)
VEHICLE: not applicable
Duration of treatment / exposure:
4 hours
Observation period:
Examinations of the skin took place after 30-60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Number of animals:
3
Details on study design:
TEST SITE
- The dorsal region of the body was removed by an electric clipper over an area of 25 cm2.
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100% cellulose patch on a piece of surgical plaster
- Type of wrap used: semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): all remnants of the test substance were carefully removed from the skin with warm tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD 404
Erythema and Eschar Formation
- No erythema ...0
- Very slight erythema (barely perceptible) ...1
- Well defined erythema ...2
- Moderate to severe erythema ...3
- Severe erythema (beef redness) to eschar formation preventing grading of erythema...4
- Not assessable ...*
- Maximum possible: 4

Oedema Formation
- No oedema...0
- Very slight oedema (barely perceptible) ...1
- Slight oedema (edges of area well defined by definite raising) ...2
- Moderate oedema (raised approximately 1 mm) ...3
- Severe oedema (raised more than 1 mm and extending beyond area of exposure) ...4
- Not assessable ...*
- Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
No signs of irritation were observed during the study.
For further details, see table 1.

Any other information on results incl. tables

Table 1. Dermal irritation testing in rabbits

Animal No.

Erythema

Mean score

Oedema

Mean score

30-60 minutes

1 day

2 days

3 days

30-60 minutes

1 day

2 days

3 days

159

0

0

0

0

0.0

0

0

0

0

0.0

160

0

0

0

0

0.0

0

0

0

0

0.0

161

0

0

0

0

0.0

0

0

0

0

0.0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the results of the study B-TEGME is not irritating to the skin.
Executive summary:

In an acute dermal irritation/corrosion study according to OECD 404, three New Zealand White rabbits were dermally exposed with the test substance.

Semi-occlusive testing of 0.5 ml undiluted B-TEGME for 4 hours showed neither erythma nor oedema on any of the three rabbits after the exposure and observation time points.

It can be occluded that B-TEGME is not irritating to the skin.