Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991-05-07 to 1991-05-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

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

Materials and methods

Test guidelineopen allclose all
Guideline:
other: Meeting Japanese MAFF (Ministry of Agriculture, Forestry and Fisheries) Testing Guidelines for Toxicity Studies (28 Januar 1985, 59 NohSan No. 4200) - Acute Dermal Toxicity Study
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): Solfit
- Physical state: Colourless liquid
- Lot/batch No.: 024141
- Storage condition of test material: Stored in the dark under ambient conditions
- Other: Specific gravity:0.96; Approximately 1 liter (gross weight 1154 g) of Solfit was received at IRI on 23 November 1990

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Limited, Manston Road, Margate, Kent
- Age at study initiation: 8 - 10 weeks
- Weight at study initiation: 204 - 324 g
- Housing: Housed by sex in polypropylene cages with mesh floors suspended over absorbent paper lined trays with a maximum of 5 animals per cage
- Diet (e.g. ad libitum): Rat and Mouse No. 1 Maintenance Diet, available ad libitum
- Water (e.g. ad libitum): Tap water, available ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21°C
- Humidity (%): 51%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle (light hours 0700 - 1900 h)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: Approximately 23 cm^2
- Type of wrap if used: The test material was applied evenly onto a gauze dressing which was applied to the shaved back. The trunk of the rat was then encircled with a strip of non-irritating tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Skin was wiped with a water dampened tissue
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500, 1000, 1500 and 2000 mg/kg for the range finding study; 2000 mg/kg for the main test

Duration of exposure:
24 hours
Doses:
500, 1000, 1500 and 2000 mg/kg for the range finding study; 2000 mg/kg for the main test
No. of animals per sex per dose:
2 in the range finding test
5 in the main test
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: They were weighed immediately prior to dosing, 7 days after dosing (main study only) and at sacrifice at the end of the 14 day observation period
- Necropsy of survivors performed: yes (sacrifice by carbon dioxide asphyxiation)
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:
In the dose ranging study there were no deaths and no abnormalities were noted at necropsy. Clinical signs, noted 2-4 h after dosing, were limited to reduced activity.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no Mortality
Clinical signs:
no clinical signs
Body weight:
Body weight gains were acceptable in males, but were slightly lower than in females.
Gross pathology:
No abnormalities were detected at necropsy.

Any other information on results incl. tables

Solfit: Acute Dermal Toxicity (LD50) Test in Rats; Test Results 2000 mg/kg

 Animal/Sex  Mortality  Clinical Signs  Necropsy Findings
 17¿  0  NAD  NAD
 18  0  NAD  NAD
 19  0  NAD  NAD
 20  0  NAD  NAD
21   0  NAD  NAD
 22¿  0  NAD  NAD
 23  0  NAD  NAD
 24  0  NAD  NAD
 25  0  NAD  NAD
 26  0  NAD  NAD

NAD = No abnormalities detected

Solfit: Acute Dermal Toxicity (LD50) Test in Rats; Body Weight 2000 mg/kg

 Animal/Sex

 Body Weight (g)         

   At Dosing  After 7 days  After 14 days  Gain (Loss)
 17¿  287  332  370  83
 18  281  318  340  59
 19  297  330  360  63
 20  324  369  404  80
 21  284  326  355  71
 Mean  295  335  365  71
 ± S.D.  18  20  24  10
22¿  204  232  227  23
 23  227  237  234  7
 24  227  244  241  14
 25  220  241  226  6
 26  231  249  240  9
 Mean  222  241  234  12
 ± S.D.  11  7  7  7

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The Median Dermal Lethal Dose (LD50) of Solfit in rats is greater than 2000 mg/kg
Executive summary:

The acute dermal toxicity potential of Solfit was investigated in rats. A dose ranging study in pairs of rats indicated that the LD50 value by dermal route is greater than 2000 mg.kg^-1. A main study dose level of 2000 mg. kg^-1 was selected accordingly. No further testing at other dose levels was necessary. In the main study, no deaths occurred and no clinical signs were noted after a 24 h dermal administration, under occlusion, of Solfit at a dose level of 2000 mg.kg^-1. The median Dermal Lethal dose (LD50) of Solfit in rats is greater than 2000 mg.kg^-1.