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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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Mecoprop
EC Number:
230-386-8
EC Name:
Mecoprop
Cas Number:
7085-19-0
Molecular formula:
C10H11ClO3
IUPAC Name:
2-(4-chloro-2-methylphenoxy)propanoic acid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Housing: Cages were made of stainless steel with wire mesh, type DKIII. Animals were housed 1 per cage.
- Water: Ad libitum tap water.
- Acclimation period: at least 1 week.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 to 24 °C
- Humidity: 30 to 70 % relative humidity
- Photoperiod: 12 hours light/ 12 hours dark (06.00 - 18.00 hours/ 18.00 - 06.00 hours)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: Dorsal and dorso-lateral parts of the trunk; about 50 cm x 50 cm.
- The test suspension was applied in the morning. The test site was clipped at least 15 hours before application.
- Type of wrap if used: The application site was covered with a semi-occlusive dressing for 24 hours.

REMOVAL OF TEST SUBSTANCE
- Washing: 24 hours after application the dressing was removed and the application site was rinsed with warm water.

TEST MATERIAL
- 0.5 % aqueous carboxymethyl cellulose formed a 30 % w/v suspension with the test material.
- Amount(s) applied: for the 4 000 mg/kg treatment 13.3 mL/kg was applied. For the 2 000 mg/kg treatment 6.7 mL/kg was applied.
- Concentration: 30 % w/v

VEHICLE
- Aqueous formulation corresponds to the physiological medium.
Duration of exposure:
24 hours
Doses:
2 000 and 4 000 mg/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Scoring of skin findings: 30 - 60 minutes after removal of the semi-occlusive dressing and at least once weekly during the following observation period.
- Recording of signs and symptoms: Several times on the day of application, and at least once each work day. Checks for moribund and dead animals twice each work day and once on holidays.
- Necropsy of survivors performed: Yes. Food was withdrawn 16 hours before sacrifice with CO2, then necropsy with gross pathological examination was performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred.
Clinical signs:
other: No abnormalities were observed in any of the test animals. Erythema was observed.
Gross pathology:
No abnormalities were detected in the necropsy of sacrificed animals.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified in accordance with EU criteria.
Conclusions:
Under the conditions of this study, the acute dermal LD50 of the test material to rats was > 4 000 mg/kg.
Executive summary:

The acute dermal toxicity of the test material was investigated in a study similar in design to OECD 402.

Ten male and female wistar rats were treated dermally with the test material at doses of 2 000 or 4 000 mg/kg for 24 hours. 30 - 60 minutes after removal of the semi-occlusive dressing and at least once weekly during the following observation period skin observations were performed. The animals were observed for 14 days before gross necropsy was performed.

No abnormalities were observed in any of the test animals but erythema was observed. No mortality occurred. Body weights increased during the observation period following test material application and no abnormalities were detected in the necropsy of sacrificed animals.

Under the conditions of this study, the acute dermal LD50 of the test material to rats was > 4 000 mg/kg.