Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline (OECD 402) study, GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report Date:
1993

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
(Feb. 1987)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid
Details on test material:
- Physical state: white powder
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
other: Tif: RAI f (SPF)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ciba Geigy Ltd. Animal Production, 4332 Stein/ Switzerland
- Age at study initiation: young adult
- Weight at study initiation: 212 -237 g
- Housing: individually; in Macrolon type 3 cages
- Diet: Rat diet (NAFAG 890 Tox, NAFAG, Gossau/SG, Switzerland); ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % (w/v) in 0.1 % (w/v) aqueous polysorbate 80
Details on dermal exposure:
TEST SITE
- Shaving: approx. 24 hours before treatment
- Area of exposure: back
- % coverage: at least 10 %
- Type of wrap if used: gauze-lined dressing was fastened around the trunk with an adhesive elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing: yes (water)
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied: 4 mL/kg bw
- Concentration (if solution): no data
Duration of exposure:
24 hours
Doses:
2,000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: Mortality was monitored twice daily on week days and once on weekends. Clinical signs were monitored daily
- Frequency of weighing: immediately before application and on days 7 and 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Highest dose tested. No mortality occurred and the only clinical sign manifested was piloerection (fully reversible within 1 day)
Mortality:
No mortalities occurred.
Clinical signs:
- Slight piloerection was seen. This is common symptom in acute dermal tests. The animals recovered within 1 day.
Body weight:
Individual body weight, their group means and standard deviations were normal and comparable to that of rats of this strain and age (see table 1)
Gross pathology:
At necropsy, no deviations from normal morphology were found.

Any other information on results incl. tables

Table 1: Table of mean body weights (n = 5); acute dermal toxicity

 

 

Dose

 

 

2,000 (mg/kg bw)

Day 0

219 ± 6.1

223 ± 9.0

Day 7

269 ± 10.7

248 ± 14.0

Day 14

319 ± 9.3

266 ± 15.7

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met