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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:
From 18.10.1988 to 24.11.1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: There are no deviations from the recommended guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl chloroacetate
EC Number:
203-294-0
EC Name:
Ethyl chloroacetate
Cas Number:
105-39-5
Molecular formula:
C4H7ClO2
IUPAC Name:
ethyl chloroacetate
Details on test material:
- Name of test material (as cited in study report): Monochloressigsäureethylester
- Physical state: colorless, clear liquid
- Analytical purity: 99.5 %
- Impurities (identity and concentrations): 0,1 % Ethanol; 0,1 % Water; 0,3 % Dichloressigsäureethylester
- Lot/batch No.: Tank vom 21.07.1988
- Storage condition of test material: refrigerated at 4 ° C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, conventional breeding
- Age at study initiation: 3-5 Months old
- Weight at study initiation: 2,6-3,5 kg
- Housing: in individual cages in air conditioned spaces (Battery cages)
- Diet (e.g. ad libitum): Altromin 2123 maintenance diet-rabbit (Altromin GmbH, Lage / Lippe), ad libitum; and hay (approximately 15 g/day)
- Water (e.g. ad libitum): deionized, chlorinated water from automated Watering, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 ºC
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light

IN-LIFE DATES: From: 18.10.1988 To: 22.11.1988

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL/patch
Duration of treatment / exposure:
4 hours
Observation period:
21 days (all animals were examined for signs of erythema and oedema, and the responses scored at 30 - 60 minutes and 24, 48 and 72 hours after the exposure; if there is damage to skin which cannot be identified as irritation or corrosion at 72 hours, additional observations were made after 7, 14 and 21 days).
Number of animals:
3 animals
Details on study design:
TEST SITE
- Area of exposure: 2,5 cm x 2,5 cm

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The remaining test substance was carefully removed with warm tap water from the skin.
- Time after start of exposure: 4 hours

SCORING SYSTEM: The erythema, eschar and oedema were evaluated numerically (used the same scoring system as described in OECD guideline. All other lesions were recorded.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.67
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
not fully reversible within: 21 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3.33
Max. score:
4
Reversibility:
fully reversible within: 14 days

Any other information on results incl. tables

30 minutes to 14 days after patch removal: slight to severe erythema.

30 minutes to 7 days: very slight to severe oedema

7 to 14 days: the skin surface was dry, brittle and finely scaled in one animal.

21 days after patch removal: two animals showed very slight erythema and dry, brittle skin surface.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal irritation test in rabbits showed that Monochloressigsäureethylester has to be considered as irritant.
Executive summary:

The acute dermal irritation test was performed to 3 Albino New Zealand rabbits (in vivo) according to OECD Guideline 404. The fur was removed from the area of about 25 cm2 in the dorsal part of the trunk, 24 hours before the start of the test. A plaster with a cellulose pad was fixed to the prepared, intact area of skin of each animal. 0.5 mL undiluted substance was applied under this plaster. After a reaction time of 4 hours, under semi-occlusive conditions, the results were determined 30 to 60 minutes, 24, 48 and 72 hours and 7, 14 and 21 days after removal of the plaster.

30 minutes to 14 days after removing the patch the animals showed slight to severe erythema, as well as hardly noticeable up to severe oedema up to 7 days afterwards. After 7 to 14 days the skin surface was dry, brittle and, in one animal, finely scaled. 21 days after removal of the patch, 2 animals showed very slight erythema and a dry, brittlle skin surface. Otherwise the irritation symptoms were to a considerable extent reversible. The acute dermal irritation test in rabbits showed that Monochloressigsäureethylester has to be considered as irritant.