Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
April 3-17,2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study under GLP, test performed before withdrawal of the guideline in 2002

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 401 (Acute Oral 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:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA
- Age at study initiation: 11-12 weeks
- Weight at study initiation: Males: 236-290 g; Females: 201-233 g
- Fasting period before study: yes 24.5 h before and 3 h after dosing
- Housing: individually
- Diet: Purina Rodent Chow #5012 ad libitum
- Water: Filtered tap water ad libitum:
- Acclimation period: 27 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE: none

MAXIMUM DOSE VOLUME APPLIED: 0.62 mL (< 1 ml/100g)

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males + 5 females
Control animals:
no
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 and 3 hours after dosing) 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)
- 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 observed
Body weight:
within normal ranges
Gross pathology:
no findings

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 in rats is > 2000 mg/kg bw
Executive summary:

The test substance was administered by gavage to 5 rats/sex at 2000 mg/kg bw. No mortality, no clinical signs, no effects on body weight and no macroscopic findings were seen. The LD50 is > 2000 mg/kg bw.