Registration Dossier
Registration Dossier
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EC number: 203-294-0 | CAS number: 105-39-5
Skin irritation / corrosion
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:
- 1 988
- 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
- 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 2-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
Constituent 1
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 substance was classified as an irritant according to Guideline 83/467/EEC.
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