3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26th August 2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Guidelines of Gaitonde Committee Annexure III (following the method of Litchfield & Wilcoxon (1949))

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

EC Number:

695-243-8

Cas Number:

500731-87-3

Molecular formula:

C18H28N2O6S

IUPAC Name:

2-hydroxy-3-({3-[(2E)-3-(4-methoxyphenyl)prop-2-enamido]propyl}dimethylazaniumyl)propane-1-sulfonate

Test material form:

other: liquid

Details on test material:

Identifier: Galaxy Sunbeataine
Physical State: Liquid
Colour: Colourless
Quantity recd. 250 ml
Date of receipt of sample: 24th August 2001

Test animals

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

Test Animal:

Species: Albino rabbits
Strain: New Zealand white
Source: National Toxicology Centre
Weight Range: 1.8 to 2.1 kg
Age: 6 to 9 weeks
Sex: male and female
Number: 2 per sex
Housing: The animals were housed singly
Diet: Pelleted feed supplied by Nav Maharashtra, Chakan Oil Mills Ltd., Pune.
Water: community tap water ad libitum
Room temperature: 19-22 degrees celsius
Relative humidity: 35-75%
Light cycle: 12 hours light and 12 hours dark

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Four rabbits, two per sex were used for this study. Approximately 24 hours before the test, the hair of the trunk was removed with the help of electric clippers, to expose 10% of the body surface. The test material in the amount of 5 g/kg or 5.0 ml/kg was applied on the skin site.

The test material was held in contact with the skin with a porous gauze and a non-irritating adhesive tape throughout the 24 hour exposure period. The animals were housed singly and were restrained with a plastic collar around their neck for 24 hours, in order to avoid the ingestion of the test material and to ensure that the test subsance does not get removed for at least 24 hours. At the end of the exposure period, residual test materia.l was removed using water.

Duration of exposure:

Test substance was applied once and left for 24 hours, followed by removal with water.

Doses:

Single dose of 5 g/kg or 5.0 ml/kg was applied to the testing area.

No. of animals per sex per dose:

Two males and two females at 5 g/kg or 5.0 ml/kg.

Control animals:

no

Details on study design:

Clinical Observations :

Any toxic symptoms and mortality were recorded at 1/2, 1, 2, 3, 4 and 24 hours and later twice a day thereafter upto 14 days to determine their general health, behaviour and moribund condition.
Any abnormality observed during this period was recorded and the subsequent progress monitored.

Body weight change:
Animals were weighed individually on the day the test material was applied, weekly thereafter and prior to sacrifice.

Necopsy:
A gross necropsy was performed on all tne animals that died during the course of the test and sacrificed at the termination of the study.

Statistics:

None stated

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animals died.

Clinical signs:

other: Clinical signs of intoxication Group I - 5.00 ml/kg : All the animals appeared normal and showed no clinical signs of intoxication after the application of the test material, till the end of the study.

Gross pathology:

Necropsy findings:

Group Dose Animals found dead Killed at termination
1 5.0 ml/kg NIL NAD

Any other information on results incl. tables

Results

A summary of the individual scores on the skin following application of Galaxy Sunbetaine-MM-30 to the rabbits.

Rabbit No.	Sex	Days Post Application
		1          2             3            7              14
1	M	0          0              0          0                0
2	M	0          0              0          0                0
3	F	0          0              0          0                0
4	F	0          0              0          0                0

 

Grand Total: 0.00

0 = no reaction

LD50 in rabbits:

Group	Dose ml/kg	No. Of animals died/No. of animals treated	% Mortality
1	5.00	0/4	NIL

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 value of the test material GALAXY-SUNBETAINE-MM-30 was found to be greater than 5.00 ml/kg (5000 mg/kg bw).

Executive summary:

Summary:

The objective of the study now reported was to determine the acute dermal toxicity of Galaxy Sunbeat MM-30 in rabbits, following the Gaitonde Committee Protocol.

The test material was applied to the 10% surface area in four rabbits, two per sex, at the limit dose (5 ml/kg or 5 g/kg). All the animals were observed for clinical signs upto 14 days after treatment.

The test material did not cause any clinical signs of intoxication in the treated animals. There was no erythema or oedema to the skin in all the rabbits during and till the end of the study.

The LD50 value of Galaxy Sunbetaine-MM-30 in rabbits by the dermal route was found to be greater than 5.00 ml/kg.