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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:
other: OECD guideline and GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 99.34 %

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.6-2.8 kg
- Housing: individually
- Diet ad libitum
- Water ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: the opposit site
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
24 hours
Number of animals:
3 (2 males and 1 female
Details on study design:
according to OECD TG 404, Scoring according to Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 5.2
Max. score:
8
Reversibility:
not reversible
Remarks on result:
other: 24 hours post application the treatment aerea showed erythema, severe reddened to black, crusts, edema, slight to severe indurations. Therefore the observation period was terminated and the rabbits were killed due to ethical reason.
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 4
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hours
Score:
ca. 1
Max. score:
4
Reversibility:
not reversible

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information
Executive summary:

N,N-dimethylbenzylamine was applied to the skin of rabbits to evaluate the irritant potency the test as performed according to OECD TG 404 and resulted in severe erythema score 4 of (max) 4 including black areas, crusts, edema, slight to severe indurations. According to these severe skin reactions observed (deep red to black injuries) the animals were kept only for an observation period of 24 hours they were killed due to ethical reason after this period (BG Chemie 1987)