Reaction mass of methyl chloroacetate and chloroacetic acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 01.03.1979 to 29.05.1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test method equivalent to OECD guideline 402. No GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

Internal guideline, valid at the time of study.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Monochloressigsäure
- Physical state: white crystalline flakes

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Own breeding
- Strain: Hoe WISKf (SPF71)
- Weight at study initiation: 160 - 208 g (x = 183 g, s = ± 13 , 08 g, n = 48).
- Housing: Animals were housed individually in plastic cages; bottom: wood shavings.
- Diet (e.g. ad libitum): Altromin 1324 (Altromin GmbH, Lage/Lippe), ad libitum.
- Water (e.g. ad libitum): Tap water, ad libitum.
The test was performed in female rats, because in preliminary tests, a higher sensitivity could be determined.

IN-LIFE DATES: From: 01.03.1979 To: 16.04.1979

Administration / exposure

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST SITE
- Area of exposure: Application on depilated back skin (ca. 30 cm²).
- Type of wrap if used: After dosage, skin covered using an alumina foil 6x8 cm, fixed by an elastic plaster (Elastoplast, 8 cm width) around the body.

Duration of exposure:

24 hours

Doses:

50; 100, 200, 400 mg/kg; concentrations used: 1, 1, 5, 5 % respectively.
200, 280, 400, 2000 mg/kg; concentration used: 40 %.

No. of animals per sex per dose:

6 female rats per group

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed weekly.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Toxicity symptoms, the mortality rate and death time were recorded.

Statistics:

LD50 calculation was based on probit analysis with a method according to Linder & Weber. The confidence limits were calculated according to Cavalli-Sforza; calculation program by Hoechst AG, department for Practical Mathematics.
To calculate the LD 50 were used only the results after administration of the 40% dilution.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

305 mg/kg bw

95% CL:

242 - 384

Mortality:

Animals died between 3.5 and 24 hours.

Clinical signs:

In dead animals during the study, the following symptoms were observed: piloerection, passivity, widened palpebral fissure , motoric unrest, belly lie, miosis, increased lachrymation, fitful breathing.
All surviving animals were free of symptoms 48 hours post application.
The behavior during the observation period was normal.

Body weight:

The body weight gain during the observation period was normal.

Gross pathology:

Dead animals during the study: lungs dark red coloured, spotted; small intestines reddened and autolysis.
After the 2000 mg/kg dose: brownish skin colouration near the application area, muscle tissue beneath deeply white-grey coloured approx. 1 mm in depth.
Surviving animals: without macroscopic findings.

Any other information on results incl. tables

Table 07.02.03_01. Mortality rate.

Dosis (mg/kg)	concentration (%)	dead animals / animals used
50	1	0/6
100	1	0/6
200	5	0/6
400	5	0/6
200	40	0/6
280	40	4/6
400	40	4/6
2000	40	6/6

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category III

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

A LD50 of 305 (242 - 384) mg/kg bw was determined by Probit.

Executive summary:

A study of the acute dermal toxicity was performed on female Wistar rats. Test method was equivalent to OECD guideline 402. Animals were exposed for 24 hours to test substance (50; 100, 200, 400 mg/kg; concentrations used: 1, 1, 5, 5 % respectively. 200, 280, 400, 2000 mg/kg; concentration used: 40 %). Six rats per dose were used. After an observation period of 14 days, a LD 50 of 305 (242 - 384) mg/kg bw was determined by Probit.