Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
16-5-2006 to 1-6-2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid methods, therefore it is considered adequate, reliable and relevant for classification.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report Date:
2006

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Chloramin B; sodium N-chlorobenzenesulphonamide trihydrate
- Substance type: Biocide
- Physical state: White to light yellow powder
- Analytical purity: 98%
- Impurities (identity and concentrations): 0.6% NaOH.
- Composition of test material, percentage of components: 77% CAS 127-52-6, 22.4% Water incl. trihydrate, 0.6% NaOH.
- Isomers composition: Not applicable.
- Purity test date: No data.
- Lot/batch No.: 54/MA/20/06
- Expiration date of the lot/batch: 03/2011
- Stability under test conditions: Stable, c.f. Chapter 4.18.
- Storage condition of test material: Stable, c.f. Chapter 4.18.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm BioTest s.r.o., Konárovice, 281 25, CZ, RČH CZ 21760152
- Age at study initiation: Not provided
- Weight at study initiation: 3.1 – 3.6 kg
- Fasting period before study: No data
- Housing: Individually in cages without bedding in conventional animal room
- Diet (e.g. ad libitum): TM-MAK 1 for rabbits and guinea-pigs pelleted standard diet ad libitum (producer: Bergman, Kocanda Mill, 252 42 Jesenice u Prahy, Czech Republic)
- Water (e.g. ad libitum): Drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. Of Law)
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C (permanently monitored)
- Humidity (%): 30-70% (permanently monitored)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 9-5-2006 To: 1-6-2006

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
other: The test substance was applied in delivered form, moistened with the smallest amount of water.
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- 0.5g (moistened with the smallest amount of water)

Duration of treatment / exposure:
4 hours
Observation period:
First animal: 3 min, 1 hour and 4 hours; second and third animal: 4 hours
Daily observations for 14 days
Number of animals:
2 males and 1 female
Details on study design:
TEST SITE
- Area of exposure: dorsal area of the trunk (6 x 6 cm)
- Type of wrap if used: The application site was covered by gauze patch, foil and cellulose cotton and held in place with non-irritating tape (Spofaplast)

REMOVAL OF TEST SUBSTANCE
- Washing: At the end of each exposure period the patch was removed and remaining sample was washed with water.
- Time after start of exposure: First animal: after 3 min, 1 hour and 4 hours; second and third animal : after 4 hours

SCORING SYSTEM:
Erythema and Eschar formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beet redness) to eschar formation preventing grading of erythema: 4
Maximum possible: 4

Oedema Formation
No oedema: 0
Very slight oedema (barely perceptible) : 1
Slight oedema (edges of area well defined by definite raising: 2
Moderate oedema (raised approximately 1 millimetre): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48 & 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 48 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 72 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
1.89
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 1 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 48 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 72 h
Score:
1.67
Max. score:
4
Reversibility:
not fully reversible within: 14 days
Irritant / corrosive response data:
There was evidence of irritant effects of different severity: well defined and moderate to severe erythema, slight oedema (animals No. 19 and No. 22) and eschar and crust formation (animal No. 21). Described effects lasted for 14 days.
During the 14-day observation period, the lesions on the skin were almost healed: the symptoms of irritation effect (crust, erythema, oedema) persisted to the end of period but in much lesser extent.
It is possible to predict, that if the observation period will last for further few days, the lesion would be fully healed. It could be presumed that the changes on the skin will be reversible.
Other effects:
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1. Skin reactions in experimental animals-grades

Time after 4-hours exposure

Observation

Rabbit No. 19

Rabbit No. 21

Rabbit No. 22

1 hour

Erythema        2

Erythema                    2

Erythema        2

Oedema          2

Oedema                      2

Oedema          2

24 hours

Erythema        2

Erythema, crust, eschar formation       4

Erythema        3

Oedema          2

Oedema          2

Oedema          2

48 hours

Erythema        2

Erythema, crust, eschar formation       4

Erythema        3

Oedema          2

Oedema          2

Oedema          2

72 hours

Erythema        2

Erythema, crust, eschar formation       4

Erythema        3

Oedema          2

Oedema         2

Oedema          1

 

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Choramine B trihydrate is irritant.
Executive summary:

The test substance, Chloramin B trihydrate, was tested in the study for acute dermal irritation/corrosion inNew Zealand Albino rabbits according to EU method B.4 and OECD TG 404.
Test substance was applied first on the skin of one rabbit. Well defined erythema and slight oedema (edges of area well defined by definite raising) were caused by 4-hour exposure to Chloramin B at 1 hour, 24, 48 and 72 hours after exposure of the test substance. In confirmatory test, other two rabbits were used. In these two test animals the skin irritation symptoms of different severity (erythema, oedema, crust and eschar formation) were observed in scheduled time intervals. No extinction of irritant lesions were recorded at 72 hours after exposure, so these three test animals were then observed until the end of observation period. During the 14-day observation period, the lesions on the skin were almost healed: the symptoms of irritation effect (crust, erythema, oedema) persisted to the end of period but in much lesser extent. The test substance is irritatant, but no symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.