Registration Dossier

Administrative data

Description of key information

Oral:The objective of the study was to determine the acute oral toxicity of "Galaxy-Sunbeat (S-382)" to albino mice following the Gaitonde Committee protocol.

The LD50 value of "Galaxy-Sunbeat (S-382)" according to the Gaitonde Commitee Guidelines, in albino mice by the oral route, following the methods of Litchfield and Wilcoxon (1949) was found to be greater than 5.0 ml/kg (5000 mg/kg bw).

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

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).

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28th September 2004
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.
Qualifier:
according to guideline
Guideline:
other: Gaitonde Committee Guidelines Annexure III following method of Litchfield & Wilcoxon (1949)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes
Species:
other: albino mice
Strain:
Swiss
Sex:
male/female
Details on test animals or test system and environmental conditions:
Test Animals:

Species: Albino mice
Strain: Swiss
Source: National Toxicology Centre
Weight Range: 20 to 24g
Age: 6 to 8 weeks
Sex: Male and female
Number: 5 male and 5 female
Housing: 5 of similar sex per cage
Diet: Pelleted food supplied by Nav Maharashtra Chakan Oil Mills Ltd., Pune
Water: Community tap water ad libitum
Room temperature: 20 to 24 degrees Celsius
Relative humidity: 40 to 60%
Light cycle: 12 hours light and 12 hours dark
Vehicle used: water
Dose volume: 1 ml/100 g

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Ten mice, five male and five female, were assigned to the dose groups. The test substance was administered once by gavage to mice. The mice were deprived of feed 3 to 4 hours before the administration of the test substance. Water was allowed ad libitum. At the end of the observation period the surviving experimental animals were sacrificed, gross necropsy performed and all the animals carefully examined.

VEHICLE: water
DOSE VOLUME : 1 ml/ 100 g

Preliminary range finding study conducted:
Two mice per sex per dose were assigned to treatment as follows:

Group No. No. of mice/sex Doses (ml/kg)
1 2 5.000
2 2 2.500
3 2 1.250
4 2 0.625

The mice were observed for toxic symptoms and mortality for 7 days after dosing.

LD50 in mice:
From the data obtained in the preliminary range find study, 10 mice (5 male and 5 female) were assigned to the treatment as follows:

Group No. No. of mice/sex Dose (ml/kg)
M F
1 5 5.000

The mice were observed for toxic symptoms and mortality for 14 days after dosing.

Doses:
Preliminary range finding study conducted:
Dose range 0.625-5.0 ml/kg

Actual Dose study: 5.0 ml/kg (5000 mg/kg bw)

No. of animals per sex per dose:
Preliminary range finding study conducted with two mice per sex per dose assigned to treatment.

LD50 in mice:
From the data obtained in the preliminary range find study, 10 mice (5 male and 5 female) were assigned to the treatment.



Control animals:
no
Details on study design:
Observations:

Clinical observations:
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: Animals were weighed individually on the day and on the day test substance was administered, weekly therefater and prior to sacrifice.

Necropsy: A gross necropsy was performed on all animals that died during the course of the test and sacrificed at the termination of the test.
Statistics:
No statistics reported.
Preliminary study:
Group No. Doses (ml/kg) No. of animals died No. of animals treated
1 5.000 0/4
2 2.500 0/4
3 1.250 0/4
4 0.625 0/4
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no CL reported
Mortality:
LD50 in mice
Mortality Data

Group No. Doses (ml/kg) Hours Days No. died/No. treated
½ 1 2 3 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14
1 5.000 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 NIL/10


Group No. Doses (ml/kg) No. of animals died/No. of animals treated Mortality
1 5.000 0/10 0%

LD50 with fiducial limits: In males and females >5.000 ml/kg
Clinical signs:
Clinical signs of intoxication:

Group 1 5.000 ml/kg: The test material caused no mortality.
Urination was seen in 2 males and 1 female at 4 hours after dosing. All the animals appeared normal and showed no clinical signs of intoxication from day 1 till the end of the study.
Body weight:
Body Weight Changes:

The percentage show body weight change compared with body weights at the start of the study (day 0)

Group Sex Group mean % weight change (days)
0 7 14
1 M 22.6 30.37 40.28
F 22.4 28.89 39.16
Gross pathology:
Necropsy finding:

Group Dose (ml/kg) Animals found dead Killed at termination
1 5.000 NIL NAD
Interpretation of results:
GHS criteria not met
Conclusions:
The LD50 value of "Galaxy-Sunbeat (S-382)" according to the Gaitonde Commitee Guidelines, in albino mice by the oral route, following the methods of Litchfield and Wilcoxon (1949) was found to be greater than 5.0 ml/kg (5000 mg/kg bw).

Executive summary:

The objective of the study was to determine the acute oral toxicity of "Galaxy-Sunbeat (S-382)" to albino mice following the Gaitonde Committee protocol.

The test material was administered by gavage to five mice per sex at the limit test. The mice were observed for 14 days after treatment.

Group 1 (5.000 ml/kg ): The test material caused no mortality. Urination was seen in 2 males and 1 female at four hours after dosing. All the animals appeared normal and showed no clinical signs of intoxication from day 1 till the end of the study.

The LD50 value of "Galaxy-Sunbeat (S-382)" in mice by the oral route was found to be greater than 5.000 ml/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
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.
Qualifier:
according to guideline
Guideline:
other: Guidelines of Gaitonde Committee Annexure III (following the method of Litchfield & Wilcoxon (1949))
Deviations:
no
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
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
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
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No animals died.
Clinical signs:
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.
Body weight:
Body weight Changes

Group Sex Group Mean% weight change


1 Days
0 7 14
M 2.00 12.52 15.28

F 1.90 10.26 13.62

The percentage show the body weight change compared with the body weights at the start of the study (Day 0)
Gross pathology:
Necropsy findings:

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

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

 

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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Additional information

Justification for classification or non-classification

The LD50 value of "Galaxy-Sunbeat (S-382)" according to the Gaitonde Commitee Guidelines, in albino mice by the oral route, following the methods of Litchfield and Wilcoxon (1949) was found to be greater than 5.0 ml/kg (5000 mg/kg bw).

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

The LD50 value of the test material GALAXY-SUNBETAINE-MM-30 according to the Gaitonde Commitee Guidelines, in rabbits by the dermal route

was found to be greater than 5.00 ml/kg (5000 mg/kg bw).

Based on the results of both studies, the test material is not considered to be classified by either the oral or dermal route.