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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:
20. Sep 1981 - 23. Sep 1981
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

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): Diisopropanolamin
- Analytical purity: 99 %
- Impurities (identity and concentrations): Monoisopropanolamine: < 0.5%

Test animals

Species:
rabbit
Strain:
other: small white russians, Chbb-SPF
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.2 - 2.7 kg
- Housing: single cages
- Diet: K4 Alleindiaet für Kaninchen (Ssniff Spezialfutter GmbH, 4770 Soest) ad libitum
- Water: tap water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 1°C
- Humidity (%): 60 ± 5 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
abraded
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: approx. 6 cm² of shaved skin of the dorsal and lateral parts of the trunk of the animals
- Type of wrap if used: mull patch (2,5 x 2,5 cm) covered with a polyethylen film (6 x 6 cm) and secured by an elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to OECD guideline 404

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
8
Reversibility:
fully reversible within: 48 h
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0.06
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no symptoms observed

Any other information on results incl. tables

Mean erythema and edema scores animal 1 - 6:

    1 h      24 h    48 h        72 h
  Erythema   Edema  Erythema  Edema  Erythema  Edema Erythema Edema
Animal 1  1  0  0  0  0  0 0 0
Animal 2  1  0  1  0  0  0  0
 Animal 3  0  0  0  0  0  0  0
 Animal 4 1  0  0  0  0  0  0 0
 Animal 5  1  0  0  0  0  0  0  0
 Animal 6  0 0  0  0  0  0  0
 mean:  0.16  0  0.16  0  0  0  0  0

Mean erythema score (24 - 48 -72 h): 0.06

Mean edema score (24 - 48 - 72 h): 0

The application of the test substance caused only slight erythema in 4/6 animals after 1 h and was fully reversible within 48 h.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information