Alkylated Naphthalene Sulphonic Acid

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 5 - 19, 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: study according to the guideline under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

other: liquid

Details on test material:

- Identity: Alkylnaphthalene sulfonic acid
- Physical state: Dark brown viscous liquid

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Millbrook Breeding Labs, Amherst, MA 01004
- Age at study initiation: 13 weeks
- Weight at study initiation: males: 2316-2645 g; females: 2296-2586 g
- Fasting period before study: NA
- Housing: individually
- Diet: Pelleted Purina Rabbit Chow #5326 ad libitum
- Water Filtered tap water ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-23°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 6X8 inches
- % coverage: 10%
- Type of wrap if used: occlusive (6-ply gauze pad wrapped with 3 inch Durapore tape)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with mineral oil, acetone and water
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied : 2000 mg/kg bw

VEHICLE : none

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5 males + 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
-BW on day 0, 7 and 14
-Clinical signs on day 1 (1, 5 and 6 hours after application) and daily thereafter (included gross evaluation of skin and fur, eyes and mucous
membranes, respiratory, circulatory, autonomic and central nervous systems, motor activity and behavior pattern)
-Erythema and oedema at approximately 25 minutes (30-60 minutes after patch removal), 48 and 72 hours after application and on day 7 and 14
- Necropsy of survivors performed: yes, gross examination on day 14

Statistics:

NA

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 seen

Body weight:

within normal ranges

Gross pathology:

no findings

Other findings:

erythema and oedema was seen in all animals (maximum grade 2) after 25 min and 24 and 72 hours. This effect was fully reversible on day 7 (only slight desquamation)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The LD50 of the test substance is > 2000 mg/kg bw

Executive summary:

The test substance was applied dermally to 5 rabbits/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. Erythema and oedema upto grade 2 were reported in all animals until 72 hours after application of the test substance. The LD50 is > 2000 mg/kg bw.