Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 March 1991 - 21 March 1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was peformed according to OECD guidelines and GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: 1,3-Propylenediaminetetraacetic acid, ferric-ammonium complex (PDTA-FeNH4)
Appearance: fine yellow crystalline powder,
Batch No.: GW-1000

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ranch Rabbits, Crawley Down, Sussex, England
- Age at study initiation: young
- Weight at study initiation: 2.26 - 2.62 kg
- Housing: They were individually housed in suspended stainless steel cages (Type RC10/L) mounted in mobile batteries (Modular Systems and Development Company Limited, London, England). The cages measured 61 x 76 x 46 cm high and were fitted with perforated counter-sunk floor panels. Atray beneath the floor was lined with absorbent crepe paper which was changed regularly.
- Diet (e.g. ad libitum): Animals had free access to a commercially available standard pelleted rabbit diet (S.Q.C. Rabbit Diet, Special Diet Services Limited, Witham, Essex, England).
- Water (e.g. ad libitum): The rabbits had free access to tap water supplied to each cage by an automatic piped system.
- Acclimation period: at least six weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 49-62
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 18 March 1991 - 21 March 1991

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated right flank of the animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): moistened with 0.2 ml distilled water

Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3 males
Details on study design:
TEST SITE
- Area of exposure: back
- % coverage: 6 cm x 6 cm
- Type of wrap if used: A single dose (0.5 g) was applied directly to the skin and covered by an unmedicated gauze patch (3 x 2 cm) which was held in place on the left test site by strips of Blenderm (3-M Company). Pads of cotton wool and elasticated bandage were used to protect the patches and ensure good contact between the skin and the test material during the four-hour exposure period. The elasticated bandage was held in place by thin strips of waterproof plaster ('Sleek' - T &J Smith and Nephew Li mited) at both edges.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Treatment sites may be gently washed with warm water and dried with paper towels to remove excess test compound adhering to the skin.
- Time after start of exposure: 4 hours

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

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

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Remarks on result:
other: No effects observed
Irritant / corrosive response data:
No dermal reaction was observed at the test site of any animal at any time during the 72 hour observation period. The control sites did not show any response to the control procedure.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Not irritating to skin.
Executive summary:

The potential of 1,3-Propylenediaminetetraacetic acid, ferric-ammonium complex, hereafter referred to as PDTA-FeNH4 to cause inflammatory or corrosive changes upon first contact with skin was assessed by semi-occluded application of 0.5 g of the test material to the closely-clipped dorsa of three New Zealand White rabbits for four hours. Dermal reactions were assessed 1, 24, 48 and 72 hours after removal of the dressings. No dermal response was observed at the test site of any animal at any time during the 72 hour observation. 1.3 Under the conditions of this test, PDTA-FeNH4 was classified as 'non-irritant' to the skin.