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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:
31. May 1967 - 05. Jun 1967
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions (1, 5, 15 min and 20 h exposure duration, no 72 h reading, 7-d observation period, 60% aqueous solution of test substance).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1967
Report Date:
1967

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
(limited documentation, 1, 5, 15 min and 20 h exposure duration, no 72 h-reading, observation period 7 d, 2 animals, 60% aqueous solution of test substance)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test substance (as cited in study report): Trimethylaminhydrochlorid
- Analytical purity: approx. 60 - 65% aqueous solution
- Impurities: 0.2 - 1% Trimethylamin
- Physical state: liquid
- Subtance number: XVII/118

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3.56 and 3.58 kg
no additional information given

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: other: untreated site served as control
Amount / concentration applied:
test substance (approx. 60% aqueous solution; 0.2 – 1% Trimethylamin)
Duration of treatment / exposure:
1, 5, 15 min and 20 h
Observation period:
7 d (readings after treatement: 24 h, 48 h, 5 d and 7 d)

Number of animals:
2 (females)
Details on study design:
TEST SITE
- Area of exposure: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): skin was washed with Lutrol (conc.) and 50% in water.
- Time after start of exposure: 1, 5, 15 min or 20 h.

SCORING SYSTEM: evaluation was performed according to the Draize Scoring System

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #1
Time point:
24/48/72 h
Score:
3
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: slight, line-like necrosis at day 5, scaling at day 7
Remarks:
This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.
Irritation parameter:
erythema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: see 'Remarks'
Remarks:
This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 5 days
Remarks on result:
other: slight, line-like necrosis at day 5, scaling at day 7
Remarks:
This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.
Irritation parameter:
edema score
Remarks:
(20 h exposure)
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
other: see 'Remarks'
Remarks:
This value was derived for the following time points: mean over 24 and 48 h. 72 hours were not evaluated.
Other effects:
Body weights (day 0 - day 7):
animal#1: 3.58 kg - 3.36 kg
animal#2: 3.56 kg - 3.34 kg

Any other information on results incl. tables

 Table 1: Details on results: Skin irritation

Exposure

Reading

Animal#1

Animal#2

Erythema

Edema

Remarks

Erythema

Edema

Remarks

1 min

All timepoints

0

0

-

0

0

-

5 min

All timepoints

0

0

-

0

0

-

15 min

All timepoints

0

0

-

0

0

-

20 h

24 h

3

2

-

1

0

-

48 h

3

2

-

0

0

-

5 d

0

0

Line-like necrosis

0

0

-

7 d

0

0

Scaling

0

0

-

Mean (24, 48 h)

3.0

2.0

-

0.5

0.0

-

Because of the strong differences between the 2 animals after test substance application, the assessment is based on the reaction of animal#1 in a worst case scenario.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
The test substance is considered as skin-irritant. Despite of restrictions regarding the actual guideline, the study is considered suitable for assessment
Executive summary:

In a primary dermal irritation study performed according to a protocol similar to the OECD test guideline 404, the test substance (approx. 60% aqueous solution; 0.2 – 1% Trimethylamin) was applied to the intact skin of 2 rabbits (Vienna White) under occlusive conditions for 1, 5, 15 min and 20 h. Erythema (mean scores (24 – 48 h): 3.00 and 0.50) was observed, but was fully reversible within 5 d and 48 h, respectively. Edema (scores: 2.00 and 0.00) was reversible within 5 d. The scores of one animal are above the threshold of classification, thus in a worst case scenario with regard to this animal, the test substance is considered irritant. The conditions were very harsh compared to the conditions requested by the guideline (20 h instead of 4 h treatment, occlusive instead of semiocclusive treatment) and no 72 h scoring was performed. But as the test substance concentration was only 60% and a strong reaction was observed in 1 of 2 animals, an irritant potential of the test substance is assumed. Besides the observed erythema, line-like necrosis was described on day 5. As on day 7 only scaling is reported, it is not considered to be of relevance for classification.