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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:
2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002
Report date:
2002

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Aspartic acid
EC Number:
200-291-6
EC Name:
Aspartic acid
Cas Number:
56-84-8
Molecular formula:
C4H7NO4
IUPAC Name:
aspartic acid
Constituent 2
Reference substance name:
L-Asparaginsäure
IUPAC Name:
L-Asparaginsäure
Test material form:
solid: crystalline
Details on test material:
Chemical name: S-(+) amino succinic acid.
Molecular formula: C4 H7 N O4.
Molecular weight: 133.10 g/mole.
Supplier: Sponsor.
Batch No.: PRCA 015.
CAS No.: 56-84-8.
Appearance: White, crystalline.
Purity: Approx. 99 %.
pH: 2.5 – 3.5 (4 g/L at 20 °C).
Melting range: 265 – 271 °C.
Solubility in water: 5 g/L at 25°C.
Conditions of storage: In the refrigerator, in the dark, may be used under light.
Stability under conditions of storage: Until December 2002.
Date of expiry: 31 December 2002.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
Strain: Crl:CD(SD)IGS BR.
Supplier: Charles River WIGA, Germany
Age: Ca. 8 weeks at the time of the administration.

Room temperature: Average of 22.1 °C.
Relative humidity: Average of 47.6 %.
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p.m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm bottom area, 18 cm height). Wire mesh lids.
Bedding material: Aspen wood chips, autoclaved.
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material.
Feed: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum. Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
Water: Tap water, ad libitum.
Acclimatisation: At least 5 days.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
The test substance was suspended in 0.1 % carboxymethyl cellulose, as an aqueous solution.
Doses:
200 and 2000 mg/kg bw.
Dose volume: 10 mL/kg bw.
No. of animals per sex per dose:
3 m + 3 f per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: Observations were performed within the periods 0 - 0.5, 0.5 - 1, 1 - 2, 2 - 4 and 4 - 6 hours after administration (p.a.) of the test substance and then at least once a day. Body weights were determined before administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality was observed.
Clinical signs:
other: No toxic effects were observed.
Gross pathology:
All animals were normal at the necropsy 14 d p.a.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
No toxic effects of the test substance were noted by signs in life and post mortem. The oral LD50 of L-aspartic acid to rats was estimated to be higher than 2000 mg/kg body weight.
Executive summary:

Methods and investigations were performed in conformance with the OECD-Guideline 423, 1996 and the Directive 96/54/EC, method B.1.tris. L-Aspartic acid was administered once by stomach intubation to 6 male and 6 female rats as a suspension in 0.1 % aqueous carboxymethyl cellulose. The dosing was performed sequentially to groups of 3 animals per sex using a starting dose of 200 mg per kg body weight and 2000 mg per kg body weight as the second dose.

No toxic effects of the test substance were noted by signs in life and post mortem. According to the decision trees of the guidelines the LD50,oral of L-aspartic acid was estimated to be higher than 2000 mg/kg body weight in rats.

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