Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-946-9 | CAS number: 1222-05-5
Skin irritation / corrosion
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:
- 1 985
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Route: .live1