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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
1987
Deviations:
no
GLP compliance:
no
Remarks:
At the time of the study conduct, GLP was not compulsory. However, the study was conducted in accordance with the principles of GLP.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: 20% of the pure active substance in water
Details on test material:
- Name of test material: DOPA-Glycinate

Test animals

Species:
rat
Strain:
other: Ico rat / OFA.SD (IOPS Caw)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Iffa-Credo, Les Oncins, 69210 L’Arbresle, France
- Age at study initiation: 5–7 weeks
- Weight at study initiation: 203–277 g
- Housing: individually
- Diet (e.g. ad libitum): pelleted complete maintenance diet, ad libitum
- Water (e.g. ad libitum): filtered drinking water, ad libitum
- Acclimation period: 10 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- % coverage: approx. 10% of the total body surface.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.98 mL/kg

Duration of exposure:
24 hours
Doses:
2000 mg/kg bw (20% aqueous solution, "product by process")
No. of animals per sex per dose:
Preliminary study: Two groups with 2 males and 2 females
Main study: 5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
clinical signs: Observations were made within 15 minutes after administration, then 1, 2 and 4 hours later and daily for the 14 day study period.
body weight: the body weight of each animal was recorded immediately before dosing on day 1, and on day 8 and 15.
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks:
as manufactured (20% aqueous solution)
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 400 mg/kg bw
Based on:
act. ingr.
Mortality:
No deaths occurred.
Clinical signs:
No behavioural abnormality was noted in the animals throughout the study period.
The all males showed a very slight to well raised erythema from day 2 to 4 as well as desquamation of the skin at the application area on days 4 and 5.
In all females a moderate to very slight erythema was noted in females from day 2 to 8, as well as desquamation of the skin on day 4 and dryness of the epidermis from day 4 to 8. The cutaneous lesions developed towards superficial eschar formation from day 5 up to day 9 in all females, then again in 3 out of them until the end of the observation period.
Body weight:
Over the 14 day study period all animals gained weight.
Gross pathology:
No abnormality was noted upon necropsy.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)
Conclusions:
The dermal LD50 (rat, male/female) of DOPA-Glycinate was >2000 mg/kg bw (as test material), corresponding to > 400 mg/kg bw as active ingredient.
Executive summary:

The acute dermal toxicity of DOPA-Glycinate was tested in Sprague-Dawley rats according to OECD guideline 402 (1987). A dose of 2000 mg/kg bw test item was applied once by the cutaneous route. No deviations from the methods prescribed by the guideline were reported.

Administration of the test material caused no mortality among the test animals.

Therefore, the LD50 was established above the limit dose of 2000 mg/kg bw in terms of test item as manufactured, corresponding to 400 mg a.i./kg bw.