Registration Dossier

Diss Factsheets

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 Study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1991

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Ethane, 2-Chloro-1,1-Dimethoxy-
IUPAC Name:
Ethane, 2-Chloro-1,1-Dimethoxy-
Constituent 2
Reference substance name:
97-97-02
IUPAC Name:
97-97-02
Constituent 3
Chemical structure
Reference substance name:
2-chloro-1,1-dimethoxyethane
EC Number:
202-624-0
EC Name:
2-chloro-1,1-dimethoxyethane
Cas Number:
97-97-2
Molecular formula:
C4H9ClO2
IUPAC Name:
2-chloro-1,1-dimethoxyethane
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Chloroacetaldehyde dimethylacetal
- Physical state: colourless liquid
- Solubility inw ater: 52g/L at 20°C
- Analytical purity: 98%

Test animals

Species:
rabbit
Strain:
Californian
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Schweizer Hof Untergröningen, Dr. Zimmermann
- Housing: individually in suspended stainless steel cages (2450 cm²)
- Diet: Raiffeisen Alleinfuttermittel 52/P for rabbits, once daily ca 180g
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22
- Humidity (%): 45-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes
Amount / concentration applied:
TEST MATERIAL: Amount applied: 0.5mL of the substance
VEHICLE: water
Duration of treatment / exposure:
4h
Observation period:
14d
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: back
- coverage: 6 cm²
- Type of wrap if used: no data, but warp was used

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, carefully
- Time after start of exposure: 4h

SCORING SYSTEM: mortality, toxic symptoms, general state of health, behaviour, body weight, skin results

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 14d
Score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: day 1-day 6
Score:
1
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: day 7
Score:
0
Reversibility:
fully reversible

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under described test conditions following skin changes resulted from the test of chloroacetaldehyde dimethylacetal in albino-rabbits:
Erythema score: 1
Edema score: 0
Up from day 7 after substance application no changes were visible. Acute systemic toxic symptoms were not recognized.
The animals showed body weight gain during the observation period.
Executive summary:

Chloroacetaldehyde dimethylacetal was tested according to OECD Guideline 404 in 3 Albino Rabbits (Amount per animal: 0.5ml).

Under the test conditions skin changes resulted, assessed with max. 1 point erythema score. There was no edema score observed. Up from day 7 after substance application no changes were observed. Acute systemic toxic symptoms were not recognized.

The animals showed body weight gain during the observation period.