L-Glutamine, L-alanyl-

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-03-27 to 1990-04-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

1984

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

475-290-9

EC Name:

-

Cas Number:

39537-23-0

Molecular formula:

C8H15N3O4

IUPAC Name:

(2R)-2-[(2S)-2-aminopropanamido]-4-carbamoylbutanoic acid

Test animals

Species:

rabbit

Strain:

other: White Russian

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Asta Pharma AG, Bielefeld, Germany
- Age at study initiation: 11 months (males); 10 - 11 months (females)
- Weight at study initiation: 2.24 - 2.77 kg (males); 2.41 - 2.84 kg (females)
- Fasting period before study: 16 h prior to treatment
- Housing: individually in stainless steel cages with grating floor
- Diet: standard diet approx. 120 g/day/animal
- Water: drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23
- Humidity (%): 35 - 65
- Photoperiod: 6 a.m. - 6 p.m. artificial lighting; 6 p.m. - 6 a.m. natural light-dark-rhythm

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE
- Area of exposure: shorn skin between shoulder and sacral region

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 h

TEST MATERIAL
- For solids, paste formed: test substance was moistened with the vehicle (1mL/g test substance)

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: continuously observed for clinical signs for the first 4 to 6 h after application and then daily; mortality was checked twice daily; body weights were recorded on Day 1 prior to administration, 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Statistics:

no

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No alterations were observed.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the study no acute toxic effect occurred after dermal application of 2000 mg/kg bw test substance. LD50 > 2000 mg/kg bw.
CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.