6-aminopenicillanic acid

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A GLP study, comparable to current guidelines with the exception of the observation period of 3 days rather than the required 14 days.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Animals were observed for 3 days, rather than the 14 days standard.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

6-Aminopenicillinic Acid

IUPAC Name:

6-Aminopenicillinic Acid

Constituent 2

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-APA (6-Aminopenicillinic Acid)
- Substance type: White powder
- Physical state: Solid
- Analytical purity: No data
- Lot/batch No.: WCD3823

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hazleton Research Products, Denver, PA
- Sex: Female
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 2.510-2.914 kg
- Housing: Rabbits were housed individually in cages sized in accordance with the "Guide for the Care and Use of Laboratory Animals" of the Institute of Laboratory Animal Resources, National Research Council.
- Diet : Purina Lab Rabbit Chow (H.F.), checked daily and added or replaced as needed according to Standard Operating Procedure PH-113. Feeders were designed to reduce soiling, bridging and scattering.
- Water : Fresh tap water ad libitum.
- Acclimation period: Minimum of 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 to 21 °C
- Humidity (%): 40 to 70 %
- Photoperiod (hrs dark / hrs light): 12 hour light cycle

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: shaved, and abraded and non-abraded skin

Vehicle:

other: test material was moistened with0.9% saline.

Controls:

yes, concurrent vehicle

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied : 500 mg/test article site

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Caudal and rostral on each flank
- Area coverage: Approximately 6 cm^2
- Type of wrap if used: The test article was applied to a small area of skin and covered with a gauze patch and loosely held in contact with the skin by means of a suitable semi-occlusive dressing and non-irritating tape for the duration of the exposure period.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed with gauze and water.
- Time after start of exposure: 4 hours


SCORING SYSTEM: Draize Evaluation of Dermal Irritation

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 60 min, 24 h, 48 h and 72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable, no effects observed

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 60 min, 24 h, 48 h and 72 h

Score:

0

Max. score:

0

Reversibility:

other: not applicable, no effects observed.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 60 min, 24h, 48h and 72h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable, no effects observed

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 60 min, 24 h, 48 h and 72 h

Score:

0

Max. score:

0

Reversibility:

other: Not applicable, no effects observed

Irritant / corrosive response data:

No effects were observed

Other effects:

No effects were observed

Any other information on results incl. tables

Table 1: Observations/Post Treatment for 6-APA

 

Rabitt No.	Sex	60 minutes				24 hours				48 hours				72 hours
		Erythema		Oedema		Erythema		Oedema		Erythema		Oedema		Erythema		Oedema
		I	A	I	A	I	A	I	A	I	A	I	A	I	A	I	A
3254	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3255	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
3256	F	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
I = Intact sites A = Abraded sites

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

Based upon the observations made in the Primary Dermal Irritation Study in rabbits, 6-APA (6-Aminopenicillinic Acid), was determined not to be a dermal irritant.