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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: done under GLP condition and acc. to OECD guideline no. 404

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Nadide
EC Number:
200-184-4
EC Name:
Nadide
Cas Number:
53-84-9
Molecular formula:
C21H27N7O14P2
IUPAC Name:
nadide
Details on test material:
- Substance type: organic
- Physical state: off-white crystalline powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: 6 weeks
- Weight at study initiation: 1.0 kg
- Housing: individually housed in labeled cages with perforated floors and shelters.
- Diet: pelleted diet approx 100 g per day
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped with electric clippers
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g of test substance moistened with 0.2 mL of the vehicle and applied to the skin
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure:150 square centimeters (10x15 cm)
- Type of wrap if used: Micropore Tape

REMOVAL OF TEST SUBSTANCE
- Washing: tap water
- Time after start of exposure: 4 hours

SCORING SYSTEM:
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) * 4
*. Where signs of necrosis or corrosion (injuries in depth) prevent erythema scoring, the
maximum grade for erythema (= 4) is given.

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 millimeter) 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1,24,48 and 72 hours
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
none
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on these results Nadide does not have to be classified and has no obligatory labelling requirements for skin irritation acc to the : GHS and EU CLP regulations
Executive summary:

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

The study was carried out based on the guidelines described in:

OECD No.404, "Acute Dermal Irritation/Corrosion" (2002)

Three rabbits were exposed to 0.5 grams of nadide, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure.

 

 No skin irritation was caused by 4 hours exposure to nadide.

Based on these results nadide does not have to be classified and has no obligatory labelling requirement for skin irritation according to the EU CLP

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