6-aminopenicillanic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1990-11-22 - 1991-04-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Commission Directive 84/449/EEC of 25 April 1984

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-aminopenicillanic acid

EC Number:

208-993-4

EC Name:

6-aminopenicillanic acid

Cas Number:

551-16-6

Molecular formula:

C8H12N2O3S

IUPAC Name:

6-amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid

Details on test material:

- Name of test material (as cited in study report): 6-AMinopenicillansäure
- Physical state: solid
- Analytical purity: 97.4%
- Lot/batch No.: 222704E
- Storage condition of test material: room temperature

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: 8-10 weeks
- Weight at study initiation: mean weight: 183g (males), 171g (females)
- Housing: 5 animals in type III Makrolon cages
- Diet (e.g. ad libitum): Altromin 1324 pellets, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ±2°C
- Humidity (%): 50 ±10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 22.11.1990 To: 06.12.1990

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

Doses:

limit dose: 2000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least twice daily
- Frequency of weighing: just before application, 7 and 14 days after application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the 14 day observation period.

Clinical signs:

other: Piloerection was observed from 1h after treatment up to day 6. One female showed a reduced general condition.

Gross pathology:

No abnormlities were detected.

Any other information on results incl. tables

Table 1: Body weights of male and female Wistar rats treated orally with 6-aminopenicillanic acid:

Animal No.	Day 1	Day 8	Day 15
Males
1	176	215	240
2	186	233	268
3	187	228	262
4	184	232	260
5	180	222	265
Mean	183	226	259
Females
1	173	197	200
2	175	197	205
3	173	191	192
4	169	184	190
5	166	184	187
Mean	171	191	195

 

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The LD50 (rat oral) of 6-aminopenicillanic acid is greater than 2000 mg/kg bw.

Executive summary:

The test substance 6-aminopenicillanic acid was administered to male and female Wistar rats by gavage. The experiment was performed as limit test with a concentration of 2000 mg/kg bw.

No animal died during the 14 day observation period. No abnormalities were detected regarding body weight development or gross pathology. Clinical signs attributed to test item administration was piloerection.

The LD50 was determined to be greater than 2000 mg/kg bw.