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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:
15 APRIL 1985 to 17 APRIL 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was carried out according to OECD guideline 404 and under GLP. However the observation time (2 weeks) was not long enough to study complete recovery.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report Date:
1985

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
The severity of lesions in conjunction with reversibility was not fully evaluated.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Galaxolide/Abbalide
- Other: preparation of the test material; No preparation of the supplied material was necessary.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: A. Smith, UK
- Diet (ad libitum): Commercial available pelleted rabbit diet (product ref. 680, Dalgety-Spillers Ltd).
- Water (ad libitum): Tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22°C
- Humidity (%): 42-65%
- Photoperiod (hrs dark / hrs light): 12/12


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): 65% HHCB in DEP
Duration of treatment / exposure:
1 hr
Observation period:
1, 24, 48, 72 and 168 hrs
Number of animals:
4
Details on study design:
TEST SITE
- Area of exposure: 2.5 cm2
- Type of wrap if used: Elastoplast adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 1 hr

SCORING SYSTEM:
Erythema and Eschar Formation (value)
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 (value)
No oedema (0)
Very slight oedema (barely perceptible) (1)
Slight oedema (edges of area well defined by definite reasing) (2)
Moderate oedema (raised approx. 1 mm) (3)
Severe oedema (raised more than 1 mm and extending boyand area of exposure) (4)











Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 hrs
Score:
ca. 2
Max. score:
3
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 168 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr
Score:
ca. 3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 hrs
Score:
ca. 2
Max. score:
2
Reversibility:
no data
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 168 hrs
Score:
ca. 1
Max. score:
2
Reversibility:
no data
Irritant / corrosive response data:
See section on results including tables and figures.

Any other information on results incl. tables

Table 1: Erythema and oedema data after HHCB exposure

1 hour observation
Rabbit# Erythema Oedema
575 1 2
579 2 3
580 2 2
582 2 3
AVG 2 3
STDEV 1 1
24 hour observation
Rabbit# Erythema Oedema
575 2 0
579 2 2
580 2 2
582 2 2
AVG 2 2
STDEV 0 1
48 hour observation
Rabbit# Erythema Oedema
575 2 0
579 2 2
580 2 2
582 2 2
AVG 2 2
STDEV 0 1
72 hour observation
Rabbit# Erythema Oedema
575 2 0
579 2 2
580 2 2
582 3 2
AVG 2 2
STDEV 1 1
168 hour observation
Rabbit# Erythema Oedema
575 1 0
579 2 1
580 2 2
582 2 2
AVG 2 1
STDEV 1 1

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In the present test the mean erythema score for Galaxolide 50 DEP exceeded 2.0 (the calculated score was 2.1). The solvent in this study, DEP, scored 0.2 for erythema and zero for oedema. The irritating effect was not reversible in 7 out of in total 15 animals in these three studies during an observation period of 7 days, as at that time point still some erythema and/or oedema was seen. The substance only needs to be classified as skin irritant based on the criteria outlined in Annex VI of 67/548/EEC (DSD). When considering Annex I of 1272/2008/EC (CLP), the substance should be regarded as non-irritating.
Executive summary:

In the present study 0.5 ml of Galaxolide 50 (65% HHCB in DEP), was placed evenly over a 2.5 cm2 of surgical lint, which was then placed on the skin of each of 4 rabbits and held by an Elastoplast adhesive bandage 10 cm wide for a period of 1 hr. Scores of skin results were given after 1, 24, 48, 72, and 168 hrs. An average score (average of all 4 animals over 24, 48, and 72 hrs) for erythema of 2.1 and for oedema of 1.5 was calculated for Galaxolide. After 168 hrs erythema and oedema were still observed in 4/4 and 3/4 animals, respectively. The average score for DEP was 0.2 for erythema and zero for oedema. The substance only needs to be classified as skin irritant based on the criteria outlined in Annex VI of 67/548/EEC (DSD). When considering Annex I of 1272/2008/EC (CLP), the substance should be regarded as non-irritating.