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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Only female rats have been used. Preliminary trials showed that there are no sex-related differences.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:

In principle according to OECD 402.
Deviation: Only females were used. Preliminary trials had shown that there is no sex-related difference.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Chloroacetaldehyde
EC Number:
203-472-8
EC Name:
Chloroacetaldehyde
Cas Number:
107-20-0
Molecular formula:
C2H3ClO
IUPAC Name:
2-chloroacetaldehyde
Test material form:
other: 45 % solution
Details on test material:
45 % aqueous solution of Monochloracetaldehyde

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:

- Source: SPF-Wistar-rats
- Weight at study initiation: 155-197 g
- Fasting period before study: 16 hours
- Housing: synthetic material cages, shavings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Hairless and intact skin on the back, approx. 30 cm2 treated with the undiluted test substance. Occlusive (aluminium foil fixed with Elastoplast 8 cm from Beiersdorf AG, Hamburg).
Duration of exposure:
24 h
Doses:
50, 100, 160, 200, 1250, 5000 mg/kg KG
No. of animals per sex per dose:
6 female rats per dose
Control animals:
no
Details on study design:
After 24 h the dressing was removed and the test substnace removed with warm water. The animals were examined once daily (not on the weeksend) for 14 days. All surving animals were sacrificed after the observation period and subject to macroscopic examination.
Statistics:
The LD50 calculation was done by probit analysis according to Lindner & Weber. Results: LD50

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 140 mg/kg bw
Based on:
test mat.
Mortality:
LD50 = 140 mg/kg body weight. Mortality occured within 60 minutes up to 7 days p.a..
Clinical signs:

Symptoms:
Crying, restlessness, restless behaviour followed
by decreased activity, closed eyes, tremor, ataxia, gasping
dispneua, general bad health condition.
The treated skin areas showed erythema, swelling, yellow discoloration,
indurcisment, necrosis.
Body weight:
no data
Gross pathology:
The macroscopic examination at autopsy of the dead animals
showed heavy erythema and oedema of the subcutis as well as
reddish discoloration of the mucosa of stomach and intestines.
Stomach and intestines were partially filled with red up to
black content.
The macroscopic examination of the survivors, killed after
14 days, did not show visible alternations.
Other findings:
none

Applicant's summary and conclusion

Interpretation of results:
Category 2 based on GHS criteria
Remarks:
Migrated information
Conclusions:
LD50 = 140 mg/kg body weight. Mortality occured within 60 minutes up to 7 days p.a.
Executive summary:

From the mortality figures the acute dermal toxicity of a 45 % aqueous solution of Monochloracetaldehyde in female rats was calculated to be 140 mg/kg.