6-aminopenicillanic acid

Endpoint summary

Description of key information

Acute toxicity by the oral route was investigated by a study which is comparable to guideline and done to GLP.

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:

1990-11-22 - 1991-04-23

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study under GLP

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

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

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

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.

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

 

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

other:

Additional information

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.