Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
3 Dec - 17 Dec 1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Version / remarks:
adopted 1984
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): T-4113
- Physical state: white powder
- Analytical purity: >96%
- Storage condition of test material: at room temperature in the dark

Test animals

Species:
rat
Strain:
other: Crl. (CD) SD BR VAF plus
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Kent, England
- Age at study initiation: 7 to 10 weeks
- Weight at study initiation: 205 - 243 g
- Housing: individually in metal cages with wire mesh floors
- Diet: standard laboratory rodent diet (Biosure, LAD 1), ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 22
- Humidity (%): 46
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 3 Dec To: 17 Dec 1990

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 5 x 5 cm clipped skin of the dorso-lumbar region
- % coverage: 10% of total body surface
- Type of wrap if used: gauze which was held in place by an impermeable dressing

REMOVAL OF TEST SUBSTANCE
- Washing: in warm water (30-40°C) and blotting dry with absorbent paper
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.0 mL/kg bw
- Concentration (if solution): 66.7% (w/v) in distilled water
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed twice daily and weighing was carried out on day1, 8 and 15 (day1 = day of dosing)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal irritation (treated areas of skin were observed daily for signs of irritation and assessed according to the Draize scoring system)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities were observed during the study period.
Clinical signs:
No clinical sigsn of systemic effects were seen.
Body weight:
Slightly low body weight gains were noted for one female on Day8 and a second one on Day15 but these rats achieved anticipated gains on Day15 and Day8, respectively. All other rats achieved anticipated body weight gains during the study period.
Gross pathology:
No abnormalitites were found at terminal necropsy.
Other findings:
- Other observations: No dermal reactions at the site of application were observed.

Any other information on results incl. tables

Table 1: Body weights

 Sex  Dose  Animal number Bodyweight in g (individual gain weekly) at 
   (mg/kg)    Day1  Day8  Day15
 Male  2000  1  243  320 (77)  384 (64)
   2  206  269 (63)  333 (64)
     3  232  310 (78)  378 (68)
     4  234  317 (83)  387 (70)
     5  231  306 (75)  377 (71)
   Mean    229  304  372
 Female  2000  6  214  238 (24)  247 (9)
     7  225  259 (34)  276 (17)
     8  205  209 (4)  225 (16)
     9  217  233 (16)  260 (27)
     10  205  221 (16)  238 (17)
   Mean    213  232  249

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
DSD: not classified
CLP: not classified