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: Study according to OECD test guideline 402 under GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
relative humidity was slightly out of range on two days with no effects on the results
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Sulfanilic Acid (sieved)
- Physical state: grey powder
- Analytical purity: > 98.5%
- Lot/batch No.: M 002/10
- Expiration date of the lot/batch: May 2012
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle — France)
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 206-241 g
- Fasting period before study: no
- Housing: individual during treatment; by 2 or 3 from day 2 onwards
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 22 °C
- Humidity (%): 40 -74 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
paraffin oil
Details on dermal exposure:
Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item.
Animals from treated group received, by topical application under porous gauze dressing, an effective dose of 2000 mg/kg body weight:
4 g or 2 g of the test item was weighed and liquid paraffin was added in a 20 mL or 10 mL volumetric glass flask, respectively.
The preparation was manually stirred to obtain a homogeneous grey to green suspension.
The preparation was administered under a volume of 10 mL/kg body weight during 24 hours.
Duration of exposure:
24h
Doses:
2000 mg/kg body weight
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 and weighing:
Systematic examinations were carried out daily to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item.
The animals were weighed on day DO (just before administering the test item) then on D2, D7, and D14.
- Necropsy of survivors performed: yes (macroscopic observations)

Statistics:
not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
none
Body weight:
no effects
Gross pathology:
no effects
Other findings:
- erythema and dryness on the treatment site were observed for two females (days 2 to 5)

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a study according to OECD test guideline 402 under GLP, the dermal LD50 of the test substance was determined to be > 2000 mg/kg bw.
Executive summary:

The test substance was applied onto the intact skin of 10 Sprague Dawley rats (5 males and 5 females) at the single dose of 2000 mg/kg body weight. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 402 dated February 24th, 1987. No mortality occurred during the study. No systemic clinical signs related to the administration of the test item were observed. An erythema, associated with dryness, was noted on the treatment site of two females on day 2 and of all females between day 3 and day 5. The body weight development of the animals remained comparable between treated and control animals throughout the study. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. In conclusion, the LD50 of the test substance is higher than 2000 mg/kg body weight by dermal route in the rat.