By-product from Guanidinoacetic acid manufacturing

Endpoint summary

Description of key information

Acute oral toxicity of By-product from Guanindinoacetic acid manufacturing was determinded in a GLP Guideline Study applying the acute toxic class method.

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:

2020-11-24 - 2021-04-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

no

Specific details on test material used for the study:

201009MA2 liquid

Species:

rat

Strain:

Wistar

Remarks:

Crl: WI(Han)

Sex:

female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

Group 1: 2000 mg / kg bw

Group 2: 2000 mg / kg bw

Based on total dissolved solids in the solution.

No. of animals per sex per dose:

Group 1: 3 females
Group 2: 3 females

Control animals:

no

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

5 000 mg/kg bw

Based on:

test mat.

Remarks:

Total dissolved solids in the solution

Mortality:

No

Clinical signs:

other: The most relevant clinical findings in the animals were moving the bedding, reduced spontaneous activity, hunched posture and piloerection. The animals recovered within up to one day post-dose.

Gross pathology:

No specific gross pathological changes were recorded for any animal.

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, a single oral application of the test item By-product from
Guanidinoacetic acid manufacturing - solution to rats at a dose of 2000 mg/kg body weight (based
on the content of dissolved solids) was associated with signs of toxicity but not with mortality.
The median lethal dose of By-product from Guanidinoacetic acid manufacturing - solution after a
single oral administration to female rats, observed over a period of 14 days is:
LD50 cut-off (rat): 5000 mg/kg bw

Executive summary:

Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral
gavage administration at a dosage of 2000 mg/kg body weight. The liquid test item was applied
undiluted. The dose was calculated based on the content of dissolved solids in aqueous solution
(18.03%).
All animals used in the study after their entrance at BSL were allowed to acclimatise to the
laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the
study and before administration for mortality/morbidity and other clinical signs. All animals were
examined for clinical signs several times on the day of dosing and once daily until the end of the
observation period. Their body weights were recorded on day 1 (prior to the administration) and on
days 8 and 15. All animals were necropsied and examined macroscopically.

All animals survived until the end of the study showing slight to moderate signs of toxicity.
The most relevant clinical findings in the animals were moving the bedding, reduced spontaneous
activity, hunched posture and piloerection. All animals recovered within up to one day post-dose.
Throughout the 14-day observation period, the weight gain of the animals was within the normal
range of variation for this strain.
At necropsy, no macroscopic findings were observed in any animal of any step.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Value:

5 000 mg/kg bw

Justification for classification or non-classification

By-product from Guanindinoacetic acid manufacturing does not have to be classified as the LD50 cut-off is 5000 mg/kg bw