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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 November 1982 to 11 January 1983
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 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Study pre-dates GLP
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
- Fasting period before study: Animals were given no feed 16 hours before administration, but water was available ad libitum.
- Housing: Animals were housed in stainless steel wire mesh cages. 5 animals per cage.
- Water: Tap water available ad libitum
- Acclimation period: At least one week

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
(0.5 % aqueous)
Details on oral exposure:
TEST MATERIAL:
- Vehicle: 0.5 % aqueous carboxymethyl cellulose forming a suspension with the test material.
- Amount applied: 10 mL/kg
- Concentration: 6.81 % w/v (681 mg/kg), 10.00 % w/v (1000mg/kg), 14.70 % w/v (14.70 mg/kg), 21.50 % w/v (2150 mg/kg)
Doses:
681, 1000, 1470, 2150 mg/kg
No. of animals per sex per dose:
5 males and 5 females per dose.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Recording of signs and symptoms several times on the day of administration, at least once each workday. Checks for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes, withdrawal of food 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination performed.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 166 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 004 - <= 1 362
Mortality:
Mortality was observed at dose levels 1000, 1470 and 2150 mg/kg in both female and male animals. At dose 1000 mg/kg, 2/10 animals had died by day 14, at dose 1470 mg/kg 9/10 animals had died by day 14 and at dose 2150 mg/kg 9/10 animals had died by day 14.
Clinical signs:
other: No abnormalities were observed at dose level 681 mg/kg during the observation period. At the higher dose levels, a wide range of symptoms were observed for both female and male animals, these include: Dyspnea, apathy, abnormal positioning, staggering, ato
Gross pathology:
Animals that died:
- General congestion.
- Stomach: bloody ulcerations in the glandular stomach in some animals; injected vessels.
- Intestines: Slightly atonic and contents mixed with blood in some animals.
- Urinary bladder: Strikingly filled in some animals.

Sacrificed animals:
- One animal (2150 mg/kg): Tip of the forestomach thickened; adhesions of the forestomach to the peritoneum and liver.
Remaining animals:
- Organs: no abnormalities detected.

Any other information on results incl. tables

Mortality During the Study









































































































Dose (mg/kg)



2150



1470



1000



681



Males



Number of Animals



5



5



5



5



Number of Dead Animals After:



1 h



0



0



0



0



1 d



0



0



0



0



2 d



4



3



1



0



7 d



4



5



1



0



14 d



4



5



1



0



Females



Number of Animals



5



5



5



5



Number of Dead Animals After:



1 h



0



0



0



0



1 d



2



2



0



0



2 d



5



4



1



0



7 d



5



4



1



0



14 d



5



4



1



0


Applicant's summary and conclusion

Interpretation of results:
other: EU Category 4, H302 Harmful if swallowed
Conclusions:
Under the conditions of this study, the acute oral LD50 of the test material was 1166 mg/kg for males and females.
Executive summary:

The acute oral toxicity of the test material was investigated in a study similar in design to OECD 401.


Five male and five female Wistar rats were treated orally with the test material at doses of: 681, 1000, 1470 and 2150 mg/kg in a single administration by gavage. The animals were observed for 14 days, before gross necropsy was performed.


Mortality and clinical abnormalities were observed at dose levels 1000, 1470 and 2150 mg/kg, body weights increased during the observation period at all doses. In the animals that died, the gross pathology found abnormalities such as stomach ulcers, slightly atonic intestines and strikingly filled bladders in some animals. In the sacrificed animal, tip of the forestomach thickened. In the remaining animals, no abnormalities were observed.


Under the conditions of this study, the acute oral LD50 of the test material was 1166 mg/kg.