Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triethanolamin T 85
- Composition of test material, percentage of components: 85 % Triethanolamine and 15 % Diethanolamine

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach (Germany)
- Mean weight at study initiation: males: 2.34 kg; females 2.41 kg
- Housing: individual
- Diet: 130 g/day (Ovator Solikanin 4 mm, Muskator-Werke, Düsseldorf, Germany)
- Water: 250 ml tap water/day
- Acclimatisation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
4 hrs
Observation period:
72 hours
Number of animals:
1 male and 2 females
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): lutrol, water (1:1)
- Time after start of exposure: 4 hrs


SCORING SYSTEM: according to Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4, 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4, 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
no data

Any other information on results incl. tables

Readings

Animal

Exposure period: 4 h

Erythema

Edema

Additional findings

4 h

1

0

0

 

2

0

0

 

3

0

0

 

24 h

1

0

0

 

2

0

0

 

3

0

0

 

48 h

1

0

0

 

2

0

0

 

3

0

0

 

72 h

1

0

0

 

2

0

0

 

3

0

0

 

Mean

24, 48, 72 h

1

0

0

 

2

0

0

 

3

0

0

 

Mean 24, 48, 72 h

1-3

0

0

 

(Calculation of the mean according to 83/467/EEC criteria of July 29th, 1983)

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Classification: not irritating