Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
24 November - 8 December 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Test material: Simazine Technical
- Appearance: White powder
- Lot No.of test material: 74
- Expiration date of the batch: September 1996
- Purity: 97.7%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the dark at 4°C

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, England
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 201 - 236 g
- Housing: Individually in metal cages with wire mesh floors
- Diet: Standard laboratory rodent diet (SDS LAD 1) available ad libitum
- Water: available ad libitum
- Acclimation period: 28 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C ± 3°C
- Humidity (%): 30 - 70%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours light (0700 - 1900) : 12 hours dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 mm x 50 mm
- % coverage: ~10%
- Type of wrap if used: The treated area was covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.

REMOVAL OF TEST SUBSTANCE
- Washing: The treated area was washed with warm (30°C to 40°C) water and blotted dry with absorbent paper.
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount applied: 2.88 mL/kg bw
- Concentration: 69.4% w/v in distilled water
Duration of exposure:
24 hours exposure
Doses:
2.0 g/kg bw
No. of animals per sex per dose:
5 rats/ sex
Control animals:
no
Details on study design:
Mortality: Cages of rats were checked at least twice daily.

Clinical signs: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days animals were observed twice a day for 14 days after dosing.

Dermal responses: Local dermal irritation at the treatment site was assessed daily.

Bodyweight: Individual bodyweights were recorded on Days 1 (prior to dosing), 8 and 15.

Macroscopic examination: All animals were killed on Day 15 and the macroscopic appearance of all examined tissues was recorded.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
There were no deaths during the study.
Clinical signs:
There were no signs of systemic reaction to treatment.
Body weight:
Slightly lower bodyweight gains were recorded for two males and four females on Day 8 with a similar trend noted for three males and one female on Day 15. All other rats achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No macroscopic abnormalities were observed for animals killed on Day 15.
Other findings:
Dermal responses: Sites of application showed no irritation or other dermal changes throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 for acute dermal toxicity to rats of Simazine Technical was found to be greater than 2000 mg/kg bw.