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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- State of aggregation : liquid
- Appearance : colourless to yellow brown
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: H 50541 H x B (Substance number: 95/452)
- Analytical purity: 98.4%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, exclusion of oxygen (under nitrogen)

OTHER SPECIFICS:
- Name of test substance (as cited in study report): 2,2'-Dimorpholinodiethylether
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dr. Thomae GmbH, Biberach
- Age at study initiation: young adult animals
- Weight at study initiation: 2.2 kg and 2.51 kg (males); 2.53 (female)
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm²
- Diet: Kliba-Labordiaet 341, Klingenthalmuehle AG, Kaiseraugust, Switzerland (about 130 g/animal/day)
- Water: about 250 mL per animal per day
- Acclimation period: at least 1 week

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

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated skin sites of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL of the unchanged test substance
Duration of treatment / exposure:
4 h
Observation period:
8 days (reading was performed 1 h, 24 h, 48 h, 72 h and 8 d after application)
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol conc. and Lutrol/water (1:1)
- Time after start of exposure: 4 h

SCORING SYSTEM: evaluation according to the Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 24 h, 48 h and 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: scaling at 72 h
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 24 h, 48 h and 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Remarks:
(3 animals)
Time point:
other: 24 h, 48 h and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Irritant response data:

Reading

Animal

Erythema

Edema

Symptoms

1 h

1

2

0

E

2

2

0

E

3

2

0

E

24 h

1

2

0

E

2

2

0

E

3

2

0

E

48 h

1

2

0

E

2

2

0

E

3

2

0

 

72 h

1

1

0

S

2

2

0

E

3

2

0

 

8 d

1

0

0

 

2

0

0

 

3

0

0

 

Mean

(24 h, 48 h, 72 h)

1

1.7

0.0

 

2

2.0

0.0

 

3

2.0

0.0

 

Mean

(1, 2 and 3)

1.9

0.0

 

E: Erythema extending beyond the area of exposure

S: Scaling

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential of the substance in New Zealand White rabbits was investigated according to OECD Guideline 404 and EU Method B.4. Based on the test results and according to the criteria of the DSD and CLP Regulation, the substance should not be classified as irritating to the skin.