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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:
31.03.1995 to 03.04.1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, UK.
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.3 to 2.61 kg
- Housing: Individually housed in suspended metal cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-21
- Humidity (%): 56-61
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 31.03.1995 To: 03.04.1995

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
Four hours
Observation period:
72 hours
Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: The back
- % coverage: No stated, but patch was 2.5 x 2.5
- Type of wrap if used: The trunk was wrapped in an elasticated corset.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with cotton wool soaked in distilled water
- Time after start of exposure: Four hours


SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all
Score:
0
Reversibility:
other: No irritation observed
Irritant / corrosive response data:
No dermal reactions observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In a GLP, skin irritation study (reliability score 1) conducted to OECD 404, undiluted ammonium salt of ATMP (no information on composition of liquid tested) was not irritating to the skin of rabbits.
Executive summary:

In a GLP, skin irritation study (reliability score 1) conducted to OECD 404, undiluted ammonium salt of ATMP (no information on composition of liquid tested) was not irritating to the skin of rabbits.