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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:
key study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Rats acutely dermally exposed to test material and observed for 14 d.
GLP compliance:
yes
Remarks:
no certificate
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 79-033-02
- Substance type: Clear liquid
- Physical state: Liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data

Test animals

Species:
rat
Strain:
other: Albino TacN(SD)fBR
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Germantown, New York, United States
- Age at study initiation: Young adult
- Weight at study initiation: 194 to 248 g
- Fasting period before study:
- Housing: Singly in wire cages in accordance with standards described in the "Guide for the Care and Use of Laboratory Animals" (DHEW publication No. (NIH) 78-23, revised 1978.
- Diet: Purina chow 5001; no further data.
- Water: Ad libitum
- Acclimation period: Yes (length not specified)
- Other: All animals examined by veterinarian during quarantine to ensure good health.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

Administration / exposure

Type of coverage:
open
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- On day prior to treatment the backs of the rats were clipped from the scapular region to the hips using clipper blades. The test material was applied evenly over the back using a B-D disposable syringe.

REMOVAL OF TEST SUBSTANCE
- Washing: Wiped with a dry cloth.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Volume applied: 5.35 mL/kg
Duration of exposure:
24 hrs
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
8 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: 1 hr, 3 hr, 5 hr, 24 hr, twice daily thereafter except weekends once daily
- Frequency of weighing: Before exposure, 14 d
- Necropsy of survivors performed: Yes - examinations of lungs, heart, liver, spleen, kidney, adrenals, bladder, stomach, intestines, plus gross examination of external carcass (fur, skin and orifices), peritoneal and pleural mucosa, internal mesentry
- Other examinations performed: Clinical observations

Results and discussion

Preliminary study:
No mortality observed in the preliminary study using 2 rats/dose exposed for 24 hrs, observed for 72 hrs with doses of 0.05, 0.16, 0.5, 1.6 and 5.0 g/kg bw .
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
All rats lethargic after 1-3 hrs; 2 animals (F-338, F-340) became ataxic but recovered within 2 hrs. Nasal and ocular discharges observed in most animals lasting approx. 24 hrs. See table II of the attached supporting information.
Body weight:
All animals gained weight (> 10 g), except F-338 which remained the same; M-243 gained only 4 g, F-340 gained 9 g. See table I of the attached supporting information.
Gross pathology:
No signs indicative of toxicity. No visible lesions in any tissue examined.

Applicant's summary and conclusion

Conclusions:
The authors found that the acute dermal LD₅₀ to rats of the test material was > 5000 mg/kg bw.