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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was performed in accordance with OECD guideline 401 and GLP standard.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Principles of method if other than guideline:
NA
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): 4,4'-Oxybis (benzenesulfonyl hydrazide)
- Analytical purity: > 99%
- Purity test date: no data
- Lot/batch No.: 990819

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: 5 weeks
- Weight at study initiation: 157-197g for male, 132-151g for female
- Fasting period before study: Rats were fasted for approximately 16 hours prior to dosing the test substance, but drinking water was freely ingested in the cage.
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:

MAXIMUM DOSE VOLUME APPLIED:

DOSAGE PREPARATION (if unusual):

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:
Doses:
0, 1000, 2000 and 3000 mg/kg
No. of animals per sex per dose:
5 males and 5 females per dose group
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs of toxicity just before the administration at 1, 2, 3, 4, 5, and 6 hrs after dosing on day 1 and once a day until day 14. Individual body weights of animals were measured just before the administration, on day 3, 7 and the day of necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,necropsy
Statistics:
The body weight changes were analyzed using the Student’s t-test.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 1 000 - <= 2 000 mg/kg bw
Mortality:
During the observation period, all males and four females died at both 2,000 and 3,000 mg/kg bw.
Clinical signs:
In case of dead rats, the paralysis of forelimb and hindlimb, cloudy eyeball, and lacrimation on day 2 after the administration were observed in those groups. The slight paralysis of hindlimb was observed in 2 males and 2 females at 1,000 mg/kg bw and 1 female rat at 2,000 mg/kg bw on day 2. In female rats, however, these signs were recovered on day 9 and 14, respectively. The other animals were not observed any sign related with the substance treatment.
Body weight:
At 2,000 and 3,000 mg/kg bw dose group, the body weights for male and female rats were significantly lower than those of the control groups on day 3.
Gross pathology:
Dead animals of the 2,000 and 3,000 mg/kg groups showed dark-red discoloration of the brain and lung, and the atrophic thymus and spleen. In scheduled necropsy, however, no macroscopic abnormalities were seen in the surviving animals.
Other findings:
None

Any other information on results incl. tables

Table1. Mortality and clinical signsof the acute oral toxicity

Sex

Group

No. of animals

Findings

Days after treatment

1

2

3

4

5

6

7

8

9

10

11

12

13

14

Male

C

5

N

5

5

5

5

5

5

5

5

5

5

5

5

5

5

T1

5

N

5

5

5

4

3

4

4

3

3

3

3

3

3

3

P*

 

 

 

1

2

1

1

2

2

2

2

2

2

2

T2

5

N

5

 

 

 

 

 

 

 

 

 

 

 

 

 

P

 

5

5

5

5

 

 

 

 

 

 

 

 

 

C

 

5

4

5

5

 

 

 

 

 

 

 

 

 

L

 

 

 

5

5

 

 

 

 

 

 

 

 

 

D

 

 

 

 

 

5

 

 

 

 

 

 

 

 

T3

5

N

5

 

1

1

1

 

 

 

 

 

 

 

 

 

P

 

5

4

1

1

1

 

 

 

 

 

 

 

 

C

 

 

2

1

1

1

1

 

 

 

 

 

 

 

H

 

 

 

 

 

1

1

 

 

 

 

 

 

 

L

 

 

1

1

1

1

 

 

 

 

 

 

 

 

D

 

 

 

3

 

1

 

1

 

 

 

 

 

 

Female

C

5

N

5

5

5

5

5

5

5

5

5

5

5

5

5

5

T1

5

N

5

4

4

3

3

3

3

4

5

5

5

5

5

5

P*

 

1

1

2

2

2

2

1

 

 

 

 

 

 

T2

5

N

5

 

 

 

 

 

 

 

 

 

 

 

 

1

P

 

5

4

2

1

 

 

 

 

 

 

 

 

 

C

 

 

1

 

 

 

 

 

 

 

 

 

 

 

P*

 

 

 

1

2

1

1

1

1

1

1

1

1

 

D

 

 

1

1

 

2

 

 

 

 

 

 

 

 

T3

5

N

5

2

2

1

1

1

1

1

1

1

1

1

1

1

P

 

3

3

4

3

1

 

 

 

 

 

 

 

 

D

 

 

 

 

1

2

1

 

 

 

 

 

 

 

Table 2. Body weights of male and female rats

Group

 

Mean body weight (g) of males

Mean body weight (g) of females

Day 0

Day 3

Day 7

Day 14

Day 0

Day 3

Day 7

Day 14

C

Mean

153.3

194.7

232.1

296.6

125.1

153.2

172.8

195.7

 

S.D.

11.1

12.0

15.1

20.7

4.2

6.9

8.6

13.3

 

N

   5

 5

   5

   5

   5

   5

  5

  5

T1

Mean

160.9

172.2

201.8

274.6

127.7

142.0

165.1

196.5

 

S.D.

7.1

23.9

41.8

39.2

5.0

10.4

7.1

9.8

 

N

  5

 5

   5

   5

   5

   5

  5

   5

T2

Mean

163.7

141.1**

0.0

      0.0

123.2

109.6**

120.4

162.4

 

S.D.

8.0

10.9

0.0

      0.0

5.7

3.8

      0.0

      0.0

 

N

5

5

  0

  0

5

5

1

1

T3

Mean

160.2

134.4**

108.6

0.0

128.0

123.8*

186.0

215.0

 

S.D.

9.3

7.1

0.0

0.0

5.9

19.4

0.0

0.0

 

N

5

5

1

   0

5

5

1

1

Applicant's summary and conclusion

Conclusions:
The acute oral toxicity of OBSH was assessed in rats following a single administration of OBSH. The study was performed in compliance with OECD guideline 401. The acute oral median lethal dose (LD50) of OBSH was estimated to be between 1000 and 2000 mg/kg bw under the test conditions.
According to CLP criteria OBSH should be classified as Acute tox 4; H302.
Executive summary:

This study was conducted to assess the acute toxicity of OBSH following a single oral administration of 0, 1000, 2000 and 3000 mg/kg bw. This study is performed in accordance with the testing guideline OECD (401).

Groups of five males and five female fasted rats were given OBSH as a single dose on Day 1 by oral gavage at a dose level of 0, 1000, 2000 and 3000 mg/kg. OBSH was administrated in corn oil.

Following a single administration of OBSH to rats, the acute median lethal oral dose for male and female rats was estimated to be between 1000 and 2000 mg/kg bw under the test conditions.

According to CLP criteria OBSH should be classified as Acute tox 4; H302.