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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Data is from study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
other: EWG Directive 84/449/EWG
Principles of method if other than guideline:
Pnimary skin irritation study with test chemical In rabbits (4-hour semi occlusive application)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
IUPAC name:1,4-dibromobutane
Mol. formula: C4H8Br2
Molecular Weight: 215.915
Smiles: C(CCBr)CBr
InChI: 1S/C4H8Br2/c5-3-1-2-4-6/h1-4H2

Test animals

Species:
rabbit
Strain:
New Zealand White
Remarks:
KFM (SPF quality)
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Kleintierfarm Madoerin AG
CH 4414 Fuellinsdorf/ Switzerland
- Age at study initiation: 14-15 weeks
- Weight at study initiation: 2.3-2.7 kg
- Housing:Individually in stainless steel cage eqiipped with an automatic cleaning and drinking system.
- Diet (e.g. ad libitum): Pelleted stardand Kuba 341, Batch 17/86 rabbit maintenance diet
- Water (e.g. ad libitum):Community tap water from ltingen. ab Libitum.
- Acclimation period:Three days under trest conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature (°C):22±3°C
- Humidity (%):relative humidity 40-70 %
- Air changes (per hr): Air-conditioned with 10-15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark, music/light period.

IN-LIFE DATES: From: To: 8 August 1986 to 25 August 1986

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): No data


NEGATIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution): No data

POSITIVE CONTROL
- Amount(s) applied (volume or weight): No data
- Concentration (if solution):No data
Duration of treatment / exposure:
4 hours
Observation period:
The skin irritation was observed at 1, 24, 48 and 72 hrs and at 7 and 14 days intervals after removing the dressing.
Number of animals:
3 animals:
1 male
2 females
Details on study design:
TEST SITE
- Area of exposure: Dorsal area
- % coverage: 100 square cm (10cm x10cm)
- Type of wrap if used: 3.0cm x 3.0 cm patch of surgical gauze, gauze was covered with semi occlusive dressing, the dressing was anchored with elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing : Washing done with lukewarm water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS : 1, 24, 48 and 72 hrs and at 7 and 14 days intervals after removing the dressing.

SCORING SYSTEM:
- Method of calculation: EEC Council Directive 83/467/EEC,

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 hr to 14 days
Score:
0.9
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 hr to 14 days
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks on result:
probability of mild irritation
Irritant / corrosive response data:
Mild erythema was observed in all three animals but the signs were reversible within 14 days.
Other effects:
No data available.

Any other information on results incl. tables

Table 5: Primary skin irritation index

Selected observations

Mean cumulative

24 hrs

1.0

48 hrs

1.3

72 hrs

 1.3

7 days

0.7

14 days

0.0

 

Table 6: Mean scores per animal

Animal

Erythema

Edema

412: Male

1.2

0

413: Female

0.6

0

413: Female

0.8

0

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Conclusions:
In a skin irritation study, a maximum score of 0.9 out of 4 was observed. Slight irritant effects were observed which were fully reversible in 14 days. Therefore the test chemical can be considered to be not irriotant to the rabbit skin.
Executive summary:

A skin irritation study was performed on 1 male and 2 female New Zealand White KFM (SPF quality) rabbits. The test chemical was applied undiluted at a concentration of 0.5 ml to the intact shaved skin semiocclusively for four hours. The skin irritation was observed at 1, 24, 48 and 72 hrs and at 7 and 14 days intervals after removing the dressing. Body weight was measured at day 1 and at termination of the study. Rabbits were observed for mortality daily. All the observations were terminated 14 days after the application of the test chemical. Rabbits were killed by an intraveneous injection of T61 into the ear vein. The skin reaction like irritation score, colouration, corrosion and toxic symptoms waere assessed according to the OECD guideline 404. The test chemical showed primary irritation score of 0.9 when applied to the intact rabbit skin. Local signs consisted a grade 0.9 erythema and grade 0.0 edema. The skin reactions were reversible until day 14. Slight coloration was observed, no corrosive and toxic symptoms were observed in the test animals.

Based on obove observations and at a score of 0.9, the test chemical can be classified as "Not irritant" according to the CLP regulation.