Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
March 1980 - April 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A limited reported study, 3 animals per sex, 3 animals with abraded skin, 24-h occlusive application. Substance in preparation

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Please see remarks below
Principles of method if other than guideline:
Principles other than guideline:
- limited reporting
- 6 albino rabbits (3 per sex)
- 3 animals with abraded skin
- 24-h occlusive application
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Physical state: off-white, fine powder
- Analytical purity: no info
(65% low nonene ANS; C10-16 alkylbenzene sulphonic acid, sodium salt 35%)
- Impurities (identity and concentrations): no info
- Composition of test material, percentage of components: no info
- Purity test date: no info
- Lot/batch No.: no info
- Expiration date of the lot/batch: no info
- Stability under test conditions: no info
- Storage condition of test material: room temperature
- Other: test article arrived on August 27, 1979; test article and container weighed 505 grams
Specific details on test material used for the study:
PETRO BAF POWDER (65% Aromatic hydrocarbons, C10-13, alkylated, sulphonated, sodium salts, low nonene; C10-16 alkylbenzene sulphonic acid, sodium salt 35%)

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Dutchland Laboratories, Inc., denver, Pennsylvania
- Age at study initiation: no data
- Weight at study initiation: 2.37 - 2.75 kg
- Fasting period before study: no info
- Housing: individually housed in metal cages, which were elevated above the droppings
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: 10 days


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


IN-LIFE DATES: From: March 20, 1980 To: April 3, 1980

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: test substance moistened with 3 ml of distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: no info
- % coverage: clipping of approximately 30% of the total body surface of the skin on the back
- Type of wrap if used: Test substance applied under a sleeve of dental dam (gauze) which was wrapped around the trunk of the animal and secured with staples. The ends of the sleeve of dental dam were fastened with Johnson and Johnson Zonas porous tape to form an airtight occlusive wrap. Each rabbit was restrained in a Newmann harness and returned to its cage for a 24-hour exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): any unabsorbed test material was removed from the skin by washing with warm tap water
- Time after start of exposure: 24-h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): dosed at 2 g/kg
- Concentration (if solution): not applicable, test substance was moistened with 3 ml of distilled water per application
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): test substance was moistened with 3 ml of distilled water per application
- Concentration (if solution): not applicable
- Lot/batch no. (if required): not applicable
- Purity: not applicable
Duration of exposure:
24 hours
Doses:
2 g/kg moistened with 3 ml of distilled water per application
No. of animals per sex per dose:
6 rabbits: 3 males + 3 females (1 male and 2 female rabbits were abraded, the other animals only clipped)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily observations for systemic toxicity, mortality and skin irritation; weighing at study initiation and termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology
Statistics:
Not applicable.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality.
Clinical signs:
One rabbit was observed to show signs of toxicity: difficulty breathing, nasal discharge, nictitating membranes reddened and swollen with marked lacrimation on days 1 through 14.
Signs of skin irritation observed were slight to moderate erythema, edema and atonia on days 1 through 9, subsiding by day 10 in the majority of rabbits. Slight desquamation increasing to marked desquamation was noted beginning on days 4 or 5, continuing throughout the study. On days 4 through 7 slight to moderate fissuring was observed. On day 4 of the study all of the rabbits' test areas were leathery to touch and eschar formation was then noted on day 5 continuing throughout the study. Exfoliation began on day 6 or 7 in four of the rabbits and days 10 and 13 on two of the rabbits.
Body weight:
All animals gained weight over the 14-day observation period.
Gross pathology:
See clinical signs.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
The single dose acute dermal LD50 of the test item , moistened with 3 ml of distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw. Because higher concentrations than 2000 mg/kg had not been tested and effects at those higher concentrations are unknown the test material was classified in Category 5 according to OECD-GHS.
Executive summary:

The test item was evaluated for its acute dermal toxicity potential in albino rabbits. The study is comparable to OECD Guideline 402 (Acute Dermal Toxicity). The study was designed and performed according to Good Laboratory Practice Standards.

For 24 hours 2 g/kg of the test substance is applied to the skin of six albino rabbits (test material moistened with 3 ml of distilled water per application). The test sites of three of the six animals were abraded. No mortalities occurred through the study. One rabbit was observed to show signs of toxicity involving difficulty breathing, nasal discharge, nictitating membranes reddened and swollen with marked lacrimation on days 1 through 14. Moderate to severe skin irritation was noted in all rabbits during the study.

Signs of skin irritation observed were slight to moderate erythema, edem and atonia on days 1 through 9, subsiding by day 10 in the majority of rabbits. Sligh desquamation increasing to marked desquamation was noted beginning on days 4 or 5, continuing throughout the study. On days 4 through 7 slight to moderate fissuring was observed. On day 4 of the study all of the rabbits test areas were leathery to touch and eschar formation was then noted on day 5 continuing throughout the study. Exfoliation began on day 6 or 7 in four of the rabbits and days 10 and 13 on two of the rabbits. Observations were up to 14 days.

The single dose acute dermal LD50 of the test item, moistened with 3 ml of distilled water and applied to the skin for 24 hours, is greater than 2000 mg/kg bw.