Registration Dossier

Administrative data

Endpoint:
skin irritation / corrosion, other
Remarks:
OECD 404 included
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and appropriate guidelines
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Qualifier:
according to
Guideline:
other: JMAFF Japanes test guidelines (2000)
Principles of method if other than guideline:
not relevant
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: FR-513
Mol. formula: C5H9Br3O
Mol. Weight: 324.92
CAS #: 36483-57-5
Description: White flakes
Batch: 039084 (taken from label)
Composition: Tribromoneopentyl alchohol 97%, Dibromoneopentyl glycol < 0.1%
Storage: At room temperature in the dark
Stability under storage conditions: Stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
Albino Rabbit , New Zealand White (SPF-Quality)
Source: Charles River Deutschland, Kisslegg, Germany
Number of animals: 3 males
Age and body weight: at least 6 weeks old and body weights were at least 1.0 kg.
Housing: Individually in labelled cages with perforated floors.
Acclimatisation: at least 5 days before start of treatment under laboratory conditions.
Diet: Standard laboratory diet
Water: Free access to tap water
Temperature (°C): 21.0 ± 3.0 °C (actual range:16.7-22.4°C)
Humidity (%): 30-70% (actual range 37-74%)
Air changes (per hr): 15
Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: The dorsal fur was clipped with electronic clippers
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 gr
Duration of treatment / exposure:
4 hr
Observation period:
1, 24, 48 and 72 hrs after exposure
Number of animals:
3
Details on study design:
see attached file on study design

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
other: 1-72hr
Score:
0
Max. score:
0
Irritant / corrosive response data:
No skin irritation was caused after 4 hrs exposure to FR-513
There was no evidence of corrosive effect on the skin
Other effects:
No staining of the treated skin by the test substance was observed and no test substance remnants were seen.
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occured.

Any other information on results incl. tables

see attached document on tables

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
FR-513 found to be non-irritant to the rabbits under the conditions of the study
Executive summary:

Primary skin irritation/corrosion with FR-513 in the rabbit was conducted according to the appropriate guidelines of OECD 404 and OPPTS 870.2500. Three rabbits were exposed to 0.5 gr of FR-513, applied onto clipped skin for 4 hr using a semi-occlusive dressing. Observations were made 1, 24, 48 and 72 hr after exposure.

No skin irritation was caused by 4 hr exposure to FR-513. Hence FR-513 was found to be non-irritant to the rabbits under the conditions of the study.