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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
July 5-19, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline not specified, but with detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline followed
Guideline:
other: no information about guideline provided
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ammonium xylene sulfonate (AXS)
- Molecular formula (if other than submission substance): no data
- Molecular weight (if other than submission substance): no data
- Substance type:
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Lot/batch No.: 8694K
- Expiration date of the lot/batch: no data
- Stability under test conditions: stable
- Storage condition of test material: no data
- Other: specific gravity = 1.121 at 25 degrees Centigrade

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Boswell
- Age at study initiation: young adult
- Weight at study initiation: 2.50-2.98 kilograms
- Fasting period before study: no data
- Housing:individually in metal cages elevated above droppings
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days minimum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: From: July 5, 1979 To:July 19, 1979

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: trunk
- % coverage: no data
- Type of wrap if used: plastic binder with adhesive tape
- Other: Prior to exposure, the trunks of the animals were clipped free of hair and the skin examined. Only those animals without skin defects or irritation were used for the study. The skin was further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of exposure. The abrasions were sufficiently deep to penetrate the stratm corneum but not deep enough to disturb the derma.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with absorbent paper towel
- Time after start of exposure: 24 hours


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): no data other than enough to cover the treatment site
- Concentration (if solution): undiluted
- Constant volume or concentration used: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): no vehicle
Duration of exposure:
24 hours
Doses:
0.5 and 2.0 g /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: observations on day of dosage and daily (5 days per week) for 14 days; weighing on day of dosage and 7 days post treatment
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs including erythema, edema, thickening, dryness, desquamation, papules

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortalities occurred in the study
Clinical signs:
At 24 hours all animals showed a moderate erythema and a minimal to moderate edema at the treatment site. This initial dermal reaction was followed by the usual sequelae of redness, thickening, dryness and desquamation, which persisted in varying degrees through 14 days. No gross signs of test compound induced adverse systemic toxicity were observed in any of the animals following application or during the 14 day observation period.
Body weight:
Body weight records showed a normal weight picture for each of the animals at 7 and 14 days post-treatment. 13 of the 20 animals showed >10% weight gain in 13 days and none showed any weight loss.
Gross pathology:
Two animals (a male at 0.5 g/kg bw and a male at 2.0 g/kg bw) had wrinkling and fissuring of the cortex of both kidneys. All other organs and tissues were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 on male and female rabbits is greater than 2000 mg/kg body weight.