Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1989-10-31 till 1989-11-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Reliable without restrictions; Guideline study (OECD 404; Irritant effects on rabbit skin) according to GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Acetoguanamine
- Physical state: solid (white powder)
- Analytical purity: 99.2 %
- Lot/batch No.: 10/08/89 AG

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Froxfield Farms (U.K.) Ltd., Petersfield, Hampshire, England
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.5 - 2.7 kg
- Housing: idividually in metal cages with perforated floors.
- Diet (e.g. ad libitum): SDS Standard Rabbit Diet (ad libitum)
- Water (e.g. ad libitum): tap water (ad libitum)
- Acclimation period: "the rabbit selected were all acclimated to the laboratory environment", but no data on time period.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): approx. 19 °C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 19 per hour
- Photoperiod (hrs dark / hrs light): lighting was controlled by means of a time switch to give 12 hours of artificial light (0700-1900 hours) in each 24 hours period.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g Acetoguanamine

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL distilled water
- Lot/batch no. (if required): 10/08/89 AG
- Purity: 99.2 %
Duration of treatment / exposure:
four hours
Observation period:
Examintation of the treated skin was made on Day 1 (i.e. approximately 30 minutes after removal of the patches) and on Days 2, 3 and 4.
Number of animals:
three
Details on study design:
TEST SITE
- Area of exposure: dorso-lumbar region
- Type of wrap if used: 2.5 cm square gauze pad

REMOVAL OF TEST SUBSTANCE
- Washing (if done): treatment site was washed using water to remove any residual test substance
- Time after start of exposure: four hours

SCORING SYSTEM:
Erythema and eschar formation:
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erytehma
4: Severe erythema (beet redness) to slight eschar formation(injuries in depth)

Oedema formation:
0: No oedema
1: Very slight oedema (barely perceptible)
2: Slight oedema (edges of area well-defined by definite raising)
3: Moderate oedema (raised approximately 1 millimetre)
4: Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 30 minutes after removal of the patches and on days 2, 3 and 4
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The treated skin of all three animals was scored for erythema and oedema. The test substance caused no adverse effects to the skin.
Other effects:
None of the animals showed any response to treatment throughout the observation period.

Any other information on results incl. tables

Table 1: Dermal reactions elicited by Acetoguanamine.

Rabbit Number and Sex

Bodyweight

(Day 1)

E = Erythema

O = Oedema

Day

1*

2

3

4

803 (female)

2525 g

E

O

0

0

0

0

0

0

0

0

804(female)

2650 g

E

O

0

0

0

0

0

0

0

0

805(female)

2670 g

E

O

0

0

0

0

0

0

0

0

* Approximately 30 minutes after removal of the dressing

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EEC Directive 83/467/EEC Annex VI Part II
Conclusions:
In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period.
Therefore no classification for skin irritation is required for Acetoguanamine.
Executive summary:

In a dermal irritation study according to OECD 404 three New Zealand White strain rabbits were semi-occlusive dermally exposed to 0.5 g of Acetoguanamine for four hours. Examination of the treated skin was made on Day 1 (i.e. approx. 30 minutes after removal of the test substance) and on Day 2, 3 and 4. None of the animals showed any response to treatment throughout the observation period. Therefore no classification for skin irritation is required for Acetoguanamine.