Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02/02/1996-16/02/1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented report of a guideline study conducted to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report Date:
1996

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OS 114454
- Molecular formula (if other than submission substance): C7H16N2O4S
- Molecular weight (if other than submission substance): 225.29
- Smiles notation (if other than submission substance): [NH4+].O=S(=O)(O)CC(C)(C)/N=C(\[O-])C=C
- InChl (if other than submission substance): 1/C7H13NO4S.H3N/c1-4-6(9)8-7(2,3)5-13(10,11)12;/h4H,1,5H2,2-3H3,(H,8,9)(H,10,11,12);1H3
- Substance type: organic
- Physical state: liquid
- Analytical purity: 50% aqueous solution
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: not specified
- Storage condition of test material: original container at room temperature

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hazelton Research Products Inc, Denver (PA), USA
- Age at study initiation: Young adult
- Weight at study initiation: 2164- 2512 grams
- Fasting period before study:
- Housing: Individual suspended mesh bottom cages
- Diet: ad libitum)
- Water: ad libitum)
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7-20.2°C (67.5-68.4°F)
- Humidity (%): 34.1-54.1%
- Air changes (per hr): Not specified
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 2/2/1996 To: 16/2/1996

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal skin
- % coverage: approximately 23
- Type of wrap if used: gauze binder with collar

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiping with deionised water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 3.45 ml/kg
- Concentration (if solution): 50%
- Constant volume or concentration used: yes
Duration of exposure:
24 hours
Doses:
4,000 mg/kg test material (2,000 mg/kg active ingredient)
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily post-administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
4 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths were observed.
Clinical signs:
Two rabbits had instances of soft stool on days 1 and 6, but this finding was determined not to be related to the test material. There were no other clinical findings. The test material induced very slight to slight erythema on all animals. Three rabbits had very slight edema. Desquamation was also observed on three rabbits. There were no other dermal fmdings. All edema subsided by day 2. All dermal irritation completely subsided by day 11 or earlier. There were no remarkable changes or differences in body weights.
Gross pathology:
Upon terminal necropsy, two rabbits displayed accessory splenic tissue, a common congenital abnormality in New -Zealand white rabbits. Dark red lungs were noted in two animals. There were no other remarkable finding.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the test substance (OS 114454) was found to be greater than 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) when administered once for 24 hours to the clipped, intact skin of male and female albino rabbits. In addition, 2000 mg/kg (based on active ingredient, 4000 mg/kg based on test substance) was found to be a No-Observable-Effect Level (NOEL) for systemic toxicity under the conditions of this study.