Bicyclo[2.2.1]heptanebis(methylamine)

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

04 June 1991 - 20 September 1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Qualifier:

according to guideline

Guideline:

other: Environmental and Health Affairs Department Notification: No.5

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: Pharmaceutical Affairs Bureau Notification: No.615

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: 49 Basic Industries Bureau Notification: No.392

Deviations:

no

GLP compliance:

not specified

Analytical monitoring:

not specified

Vehicle:

no

Details on test solutions:

5.0 g (bulk) of the test substance were weighed into a 500 mL graduated flask, and ion-exchanged water was added up to the mark on the flask to prepare a 1 %-concentration (w/v) solution. This solution was used as the stock solution for preparing testing water at the different administration concentration levels. 5 liters each of the testing liquids - 0, 75, 100, 133 (mg/L), were prepared by diluting the stock solution with dechlorinated water as described below.
37.5 mL of 1 %-concentration (w/v) stock solution were diluted to 5 liters (75 mg/L)
50 mL of 1 %-concentration (w/v) stock solution were diluted to 5 liters (100 mg/L)
66.5 mL of 1 %-concentration (w/v) stock solution were diluted to 5 liters (133 mg/L)
Control: 5 liters of dechlorinated city water

Test organisms (species):

Oryzias latipes

Details on test organisms:

TEST ORGANISM
- Length at study initiation: 3.0 - 3.8 cm (average: 3.4 cm)
- Weight at study initiation: 0.23 - 0.47 g (average: 0.33 g)

ACCLIMATION
- Acclimation period: 7 days before the test. Fish were kept in a fish-keeping bath in the room up to the start of the acclimatization after completion of immersion bathing.

Test type:

not specified

Water media type:

not specified

Limit test:

no

Total exposure duration:

48 h

Test temperature:

24.2 - 25.1 °C

pH:

7.1 - 9.9

Dissolved oxygen:

4.6 - 7.9 mg/L

Nominal and measured concentrations:

Based on the results of a preliminary test for 48-hour LC50 value (100 mg/L or above), the following administration concentration levels were set: 0, 75, 100, 133 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel fill volume: 5 L
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1

EFFECT PARAMETERS MEASURED
Survival was assessed at 1, 3, 6, 24 and 48 hours

Reference substance (positive control):

yes

Remarks:

Mercuric chloride

Key result

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

>= 133 mg/L

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

48-hour LC50 value: 133 mg/L or above
No abnormality was detected in the behaviour of the test fish actually exposed to the test material and the test results reflect the results of the preliminary test, the value of the rate suggests that the test material is practically non-toxic to the test fish.

Results with reference substance (positive control):

In parallel with the LC50 measurement test, test for determination of resistance of the same acclimated lot of Orizias latipes against mercuric chloride was conducted for the purpose of judging the validity of the results of the LC50 measurement test.
The results were as follows:
24-hour death rate at Hg 0.5 ppm: 30 % (specified value: 20 % or lower)
24-hour survival rate at Hg 1.0 ppm: 0 % (specified value: 20 % or lower)
The 24-hour death rate of 30 % deviates to some extent from the judgment criteria specified for the test in SOP T-414 (Acute toxicity test on fish for the setting of the concentration of test substances) of the Laboratory. However, since no abnormality was detected in the behaviour of the test fish actually exposed to the test substance and the test results described reflect the results of the preliminary test, the value of the rate suggests that the test substance is practically non-toxic to the test fish. Therefore, it was considered that there was no need for conducting a test again, and the results were judged to be valid. The results of the test conducted for determination of resistance against mercuric chloride were within the range of the specified value.

Sublethal observations / clinical signs:

Results

Test material concentration (mg/L)	Exposure period (hours)
	1	3	6	24	48
0	0/10	0/10	0/10	0/10	0/10
75	0/10	0/10	0/10	0/10	0/10
100	0/10	0/10	0/10	0/10	0/10
133	0/10	0/10	0/10	0/10	0/10

Dead fish/ Tested fish

Validity criteria fulfilled:

yes

Conclusions:

48-hour LC50 value: 133 mg/L or above.

Executive summary:

The acute toxicity of the test material to fish was investigated in a study which was conducted in accordance with

Environment and Health Affairs Department Notification: No.5

Pharmaceutical Affairs Bureau Notification: No.615

49 Basic Industries Bureau Notification: No.392

During the study groups of 10 Orizias Latipes were exposed to test material concentrations of 0, 75, 100 and 133 mg/L. Survival was assessed at 1, 3, 6, 24 and 48 hours.

Under the conditions of the study none of the fish died and no abnormality was detected in the behaviour of the test fish exposed to the test material. The 48 hour LC50 was concluded to be in excess of 133 mg/L, the highest concentration tested.

Description of key information

48 -hour LC50 ≥ 133 mg/L (Oryzias latipes), Environmental and Health Affairs Department Notification: No.5, Environmental and Health Affairs Department Notification: No.5, 49 Basic Industries Bureau Notification: No.392 (1991)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

133 mg/L

Additional information

The acute toxicity of the test material to fish was investigated in a study which was conducted in accordance with Environment and Health Affairs Department Notification: No.5

Pharmaceutical Affairs Bureau Notification: No.615

49 Basic Industries Bureau Notification: No.392

During the study groups of 10 Orizias Latipes were exposed to test material concentrations of 0, 75, 100 and 133 mg/L. Survival was assessed at 1, 3, 6, 24 and 48 hours.

Under the conditions of the study none of the fish died and no abnormality was detected in the behaviour of the test fish exposed to the test material. The 48 hour LC50 was concluded to be in excess of 133 mg/L, the highest concentration tested.