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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Relatively well reported study according to guideline/standard.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test compound: PDTN
Appearance: white crystalline solid
Chemical name: Acetonitrile,2,2',2'',2'''-(1,3-propanediyldinitrilo)tetrakis-
Batch no: JNN98038
Composition: PDTN 99.2±1.0% m/m; water 0.5±0.1% m/m
Storage: at room temperature in the dark
Expiry date: 1 June 2000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands
- Age at study initiation: 8 weeks
- Weight at study initiation: 1367-1762 g
- Housing: individually in cages with perforrated floors
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (no exact data reported)
- Humidity (%): 50 (no exact data reported)
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 9 To: 12 June 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: powder was moistened (see below)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): undiluted
The test substance was ground to a powder using a pestle and mortar prior to weighing. The powdery test substance was
moistened with water (Milli-Q), immediately before application, to ensure close contact with the animal's skin.

Duration of treatment / exposure:
4 h
Observation period:
1, 24, 48 and 72 h
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: 2 x 3 cm
- % coverage: 10 x 15 cm was clipped
- Type of wrap if used: a non-woven patch was mounted on Micropore tape which was wrapped around the trunk and secured
with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue- Time after start of exposure: 4 h

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

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

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable as there were no dermal reactions at all at any of the time points
Irritant / corrosive response data:
There were no dermal reactions noted at any of the time points
Other effects:
No symptoms of systemic toxicity.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
There were no dermal reactions; thus the test material was not irritating to rabbit skin
Executive summary:

Primary skin irritation/corrosion study with PDTN in the rabbit (4 -hour semi-occlusive application).

The study was carried out based on the guidelines described in: EC Commission Directive 92/69/EEC, 8.4 and OECD No.404. Three rabbits were exposed to 0.5 grams of PDTN, applied onto the clipped skin for 4 hours using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to PDTN. Based on the results and according to the OECD-GHS criteria for classification, PDTN does not have to be classified for skin irritation.