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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:
10/03/1983 - 28/03/1983
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed in a toxicological institute under supervision of a veterinarian. Even though, no specific guideline was followe the test was performed similar to the OECD guideline 423.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
not specified
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
White colored powder 99.5% purity.

Test animals

Species:
rat
Strain:
Wistar
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Winkelmann, Borchen
- Age at study initiation:
males: 48-51 days;
females: 59 days
- Weight at study initiation:
males: 0.127 - 0.139 kg
females: 0.128 - 0.134 kg
- Fasting period before study:
16 hours before start of the test
- Housing:

- Diet (e.g. ad libitum):
ad libitum
- Water (e.g. ad libitum):
ad libitum
- Acclimation period:
5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):
21 +- 2
- Humidity (%):
55 +- 5
- Photoperiod (hrs dark / hrs light):
12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: tragacanth
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
238 mg/ml
- Amount of vehicle (if gavage):
21.5 ml/kg

Doses:
5110 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 110 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occured during the observation period of 14 days.
Clinical signs:
no adverse clinical signs observed
Body weight:
no data
Gross pathology:
no data

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
L-Histidine does not show acute toxicity in rats at a concentration of 5110 mg/kg.
Executive summary:

In this study the acute toxicity of L-histidine was assessed in a similar way as in the OECD Guideline 423, in rats via gavage.

Five animals were dosed with a dose of 5110 mg/kg, whereafter they were observed for 14 days.

No mortality occured and no adverse clinical signs were observed.

Even though no NOAEL was determined in this study, the results indicate that there were no effects at a concentration of 5110 mg/kg.