Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to GLP and valid study methods, therefore the study 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:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Test type:
standard acute method
Limit test:
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 substance
- Analytical purity: 77% (CAS 127-52-6).
- Impurities (identity and concentrations): 0.6% NaOH.
- Composition of test material, percentage of components: 77% CAS 127-52-6 (98% pure), 22.4% Water, 0.6% NaOH.
- Isomers composition: Not applicable.
- Purity test date: No data.
- Lot/batch No.: 13102006
- Expiration date of the lot/batch: 10/2011
- Stability under test conditions: Stable, c.f. Chapter 4.18.
- Storage condition of test material: Stable, c.f. Chapter 4.18.

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
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: 7-9 weeks at the time of application
- Weight at study initiation: Range at application: 181.65 – 241.60 g
- Fasting period before study: No data
- Housing: Animal room with monitoring conditions; one animal in one plastic cage; sterilized shavings of soft wood as bedding
- Diet (e.g. ad libitum): ST 1 BERGMAN complete pelleted diet ad libitum (producer: Mill Kocanda,
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: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C (permanently monitored)
- Humidity (%): 30-70% (permanently monitored)
- Air changes (per hr): Not provided
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: 14-11-2006 To: 6-12-2006

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: The test substance was applied in delivered form, moistened with the smallest amount of water.
Details on dermal exposure:
TEST SITE
- Area of exposure: back of animals (approx. 6 x 6 cm)
- Type of wrap if used: The application site was covered by mull, plastic foil and held in contact by plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The occlusive dressing and remains of the test substance were removed with water.
- Time after start of exposure: After 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The amount of test substance for each animal was weighed out (according to its body weight and the dose) immediately before application.
The test substance in delivered form (moistened with the smallest amount of water) was applied on the depilated area of skin.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Weighing: Before application, 8th, and 15th day of study
Mortality: Daily
Clinical signs: Daily (First day: twice (30 minutes and 3 hours after application), second day: twice (in the morning and in the afternoon) and daily thereafter for 14 days).
Observations included changes in skin and fur, eyes, visible mucous membranes, nutritive condition, autonomic and central nervous systems, psychic activity, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also presence of tremors, convulsions, salivation, diarrhea, lethargy, sleep and coma was carefully observed.
- Necropsy of survivors performed: yes. 15thday of study. Size, colour, shape, structure and consistency of organs were evaluated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death of animals was observed during 14 days observation period.
Clinical signs:
No clinical signs of toxicity were observed during the study in all animals.
In all test animals the skin irritation symptoms (crusts) of the test area were observed in scheduled time intervals. During the 14-day observation period the lesion on the skin were almost healed. In all animals the crusts persisted to the end of period but in much lesser extent. It is possible to predict, that if the observation period lasted for further few days, the lesion would be fully healed. Changes on the skin were reversible.
Body weight:
Weight increments in all animals were in physiological range.
Gross pathology:
Macroscopic changes were diagnosed during pathological examination in all animals (skin: crusts, spleen: granular surface).

Any other information on results incl. tables

Table 1 Body weight of animals [in grams]; Dose: 2000 mg.kg-1

Animal No.

Before application M/F*

8thday

15thday

Bodyweight gain

1

237.89/181.65

292.87 /195.38

325.06 /212.45

87.17 /30.80

2

229.64 /201.63

259.54 /225.23

292.24 /241.16

62.60 /39.53

3

233.39 /207.91

294.80 /217.25

342.58 /236.21

109.19 /28.30

4

241.60 /194.28

289.45 /207.63

323.74 /226.09

82.14 /31.81

5

231.18 /207.01

262.26 /210.96

298.99 /218.22

67.81 /11.21

*M- male/F-female

Table 2 Clinical observation; Dose: 2000 mg.kg-1; Sex: M and F

Animal No.

Tendency for death/death

Toxic effect description

1

no/no

No clinical signs of toxicity; skin crusts

2

no/no

No clinical signs of toxicity; skin crusts

3

no/no

No clinical signs of toxicity; skin crusts

4

no/no

No clinical signs of toxicity; skin crusts

5

no/no

No clinical signs of toxicity; skin crusts

Table 3 Pathological examination; Dose: 2000 mg.kg-1; Sex: M and F

Animal No.

Toxic effect findings for M and F

1

Skin crusts; spleen – granular surface

2

Skin crusts; spleen – granular surface

3

Skin crusts; spleen – granular surface

4

Skin crusts; spleen – granular surface

5

Skin crusts; spleen – granular surface

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the study results the value of LD50 dermal of the test substance Chloramin B for rats of both sexes is higher than 2000 mg/kg bw.
Executive summary:

Chloramine B trihydrate was tested for dermal toxicity in a limit test with two groups of animals (5 males and 5 females) at the dose of 2000 mg/kg bw. The test substance was applied occclusively on the shaved skin of the test animals moistened witht a small amount of water for 24 hours. The test animals were observed 14 days after application, afterwards sacrificed and necropsy for macroscopic examination of the organs was performed. The test substance applied at the dose 2000 mg/kg bw did not cause death of animals. No clinical signs of toxicity were observed during the study in all animals, except for symptoms of skin irritation which were almost healed. Macroscopic changes were diagnosed during pathological examination in all animals (skin: crusts; spleen: granular surface). According to the study results the value of LD50 dermal of the test substance Chloramin B for rats of both sexes is higher than 2000 mg/kg bw.