Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, comparable to guideline/standards

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Acute oral toxicity or LD50 value was determined by oral administration of test substance to four dose groups of rats. Subsequently observations of effects (such as clinical signs, cage side observation) and deaths were made for 14 days.
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material: Monoethanolamine salt of dodecyl benzene sulfonic acid; MEA-LAS (XTW-369)
- TSIN: UDX-4689
- Substance type: Pure active substance
- Physical state: Not reported
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Density: 1.34 g/mL
- pH: 7.5-8.5

Test animals

Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: The animals were obtained from Charles River Laboratories
- Weight at study initiation: 190-300 g
No other details on test animals and environmental conditions are provided in the study report.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 40% w/w
MAXIMUM DOSE VOLUME APPLIED: Not reported
Doses:
950, 1330, 1860 and 2600 mg/kg bw
No. of animals per sex per dose:
10 animals/dose. Sex of animal is not specified
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed daily for clinical sign and symptoms.
- Necropsy: Yes, necropsy was performed.
- Other examinations performed: Animals were observed for motor activity increase, motor activity decrease, respiratory rate increase, respiratory rate decrease, loss of righting reflex, loss of corneal reflex, pupillary response, fine body tremors, coarse body tremors, blanching, gasping, salivation, abdominal griping, diarrhea and excess urination.
Statistics:
Not reported

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 570 mg/kg bw
Based on:
act. ingr.
95% CL:
1 390 - 1 790
Mortality:
950 mg/kg bw: No mortality observed (0/10)
1330 mg/kg bw: 2 animals died out of 10 (2/10)
1860 mg/kg bw: 8 animals died out of 10 (8/10)
2600 mg/kg bw: All animals died (10/10)
Clinical signs:
Loss of righting reflex, loss of corneal reflex and pupillary response were observed in a few animals treated with the test substance.
Body weight:
Not reported
Gross pathology:
No abnormalities related to test substance were observed in any of the test groups.
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
The acute oral LD50 of Monoethanolamine salt of dodecyl benzene sulfonic acid (MEA-LAS) when administered as 40% w/w aqueous solution in male and female rats was determined to be 1570 mg/kg bw, based on active level. MEA-LAS is therefore classified as OECD GHS Toxicity Category IV (Harmful if swallowed).
Executive summary:

The objective of the study was to determine the acute oral toxicity of Monoethanolamine salt of dodecyl benzene sulfonic acid (MEA-LAS) when administered as 40% w/w aqueous solution to male and female rats.

The test substance was diluted in water and administered orally to Charles River CD rats (weighing 190 -300 g) at the following dose levels:

950, 1330, 1860 and 2600 mg/kg bw

There were ten animals/dose group. Animals were observed for mortality and clinical signs daily for 14 d.

The clinical signs and mortality observed in tested groups were as follows:

0/10, 2/10, 8/10 and 10/10 animals died at 950, 1330, 1860 and 2600 mg/kg bw dose levels respectively. Loss of righting reflex, loss of corneal reflex and pupillary response were observed in a few animals treated with the test substance.

No abnormalities were noted in any of the test groups upon gross examination at necropsy.

Based on the above, the acute oral LD50 of Monoethanolamine salt of dodecyl benzene sulfonic acid (MEA-LAS) when administered as 40% w/w aqueous solution in male and female rats was considered as 1570 mg/kg bw, based on active level. MEA-LAS is therefore classified as OECD GHS Toxicity Category IV (Harmful if swallowed).