Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-07-18 to 1990-07-23
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987), but lack of data on the purity / quality of the sample tested.
Remarks:
Test according to OECD guideline 404 and according to the US-GLP regulations (U.S. Fed. Reg., Title 21, CFR, Part 58, September 4, 1987), but lack of data on the purity / quality of the sample tested.

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:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Hydroxyambran

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Animals:
Species: rabbit
Strain: White New Zealands
Source: Harald Schriever, Kaninchenfarm, D-2740 Bremervörde, Neuendamm 88
Date of receipt July 10, 1990
Acclimation period: at least 7 days
Animal selection: random
Animal identification: with individual earmarks; cage labelled with the following information: earmark, sex, date of study initiation, project no.
Weight range at
study initiation: 2.4 - 2.8 kg

Husbandry:
Housing: individual housing (50 x 45 x 40 cm, L x B x H) in a battery of cages, each equipped with a paper roll disposal system.
Illumination: artificial lighting (120 lux) from 7.00 a.m. – 7.00 p.m.
Temperature: 18 +/- 2 °C
Relative humidity: 50 – 85 %
Measurement: with thermohygrometer twice daily
Diet: Administration: ad libitum
Manufacturer: Ssniff Spezialdiäten GmbH, 4770 Soest Westfahlen
Name: Ssniff-MÜ Z (Alleindiät für Zuchtkaninchen)
Form: Pellets
Water: Administration: ad libitum
System: drinking nipples
Quality: drinking water as for human consumption
Quality control: analytical and bacteriological controls every six months

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.5 ml on approx. 6 cm²
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3
Details on study design:
Preparation of the Animals:
Prior to test initiation, all animals were acclimated to laboratory conditions for at least 7 days. 24 h before treatment, fur was removed with electric clippers from an area of roughly 8 x 15 cm on the back of each animal. The skin was subsequently examined for abrasion and animals with healthy, intact skin were then earmarked for individual identification.

Preparation of the Test Article:
The test article was applied undiluted.

Procedure:
In each animal, 0.5 ml of the test article were applied to the test site (approx. 6 cm² in size) an adjacent area of untreated skin serving as a control. Each test area was covered with a semi-occlusive dressing consisting of Kosmoplast (Medilog), which was held in place by non-irritating tape Elastoplast (Beiersdorf Ag, Hamburg), and Stülpa (P. Hartmann AG, Heidenheim /brenz), which enveloped the whole animal’s trunk. At the end of the 4h exposure period, the dressing was removed and any residual sample was carefully washed away.

Observations:
Signs of erythema and oedema were recorded at 30-60 min, 24, 48 and 72 h after patch removal. Dermal irritation was evaluated according to a same scheme as presented in the REGULATION (EC) No 44/2008, B.4.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 30-60 min
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 30-60 min
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Not any sign for irritation/corrosion was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test article "Hydroxyambran" can be classified as "not irritant".
Executive summary:

The acute dermal iritation/corrosion of Hydroxyambran was determined according to the OECD Test Guideline 404 in rabbits.

Not any sign for irritation/corrosion was observed.

The test article "Hydroxyambran" can be classified as "not irritant".