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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 March 2010 to 10 August 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study, according to the OECD 402 technical guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Flue dust, portland cement
EC Number:
270-659-9
EC Name:
Flue dust, portland cement
Cas Number:
68475-76-3
Molecular formula:
It is a UVCB.
IUPAC Name:
tricalcium dipotassium silanedione carbonate sulfate silicate
Details on test material:
Characterization of the test substance
Date of receipt : 4 March 2010
Test material name: Flue Dust T (REACH)
Chemical name: Flue dust, Portland cement clinker (EC number 270-659-9)
Other name : Cement kiln dust
Batch number : 12-2009
CAS Reg. no. : 68475-76-3
Storage conditions: ambient temperature
Appearance : beige/grey powder
Expiry date : 1 December 2010
TNO dispense number: 10005B

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
Species : Wistar outbred rat; Crl:(WI) WU BR
Supplier : Charles River, Germany
Sex and age : males and females, at least ca 8 weeks old at the start
Acclimatization period: at least 5 days
Caging : a maximum of 5 animals/sex per macrolon cage with sterilized wood shavings (Lignocel) as bedding material and environmental enrichment (Environ-Dry); individual housing during dermal expo¬sure.
Identification : ear tattoo or by marker pen
Lighting : 12 hours light/12 hours dark cycle
Temperature during testing : 20-24 oC.
Relative humidity during testing: 45-65%. The upper limit was incidentally up to 80% (not exceeding ca 1-2 hours) because of meteorological circumstances and/or wet cleaning of the room.
Ventilation : ca 10 air changes/hour
Diet/water : standard laboratory diet ad libitum. Each batch of this diet is analysed by the supplier (SDS Special Diets services, Whitham, England) for the nutrients and contaminants and the results are kept available in the archives. Tap water (N.V. Vitens) ad libitum. Results of routine physical, chemical and microbiological examination of drinking water as conducted by the supplier are kept available in the archives. The results of diet and water analyses were considered acceptable for this study.

Administration / exposure

Type of coverage:
not specified
Vehicle:
water
Duration of exposure:
24 h
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
After the acclimatization period, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. The next day, the test substance was applied to the clipped area of 5 male and 5 female rats by weight in one dose level of 2000 mg of the test substance per kg body weight.
A 500 mg/ml test concentration was prepared in water. The weight variation of the animals (per sex) did not exceed plus or minus 20% of the mean body weight at the start of the study. The amount of the test dilution was calculated for each animal individually and distributed over a gauze patch, measuring 5x 5 cm, i.e. an exposure area of at least 20 cm² (ca 10% of the total body surface). The loaded patch was placed on the clipped skin and fixed to the application site by means of adhesive tape and the entire trunk of the rat was wrapped with a bandage ¬to maintain the test patch in position and to retard evapora¬tion of volatile substances. During the exposure period the animals were housed individually. After an exposure period of circa 24 hours the materials and residues of the material applied were removed with lukewarm water as much as possible without damaging the skin. The animals were observed for mortality up to 14 days after treatment.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality or clinical signs were observed during the 14-day study period.
Clinical signs:
other: Individual skin reactions recorded on days 1, 3, 7, and 14 of the study are presented in table 2. Upon removal of the patch, it appeared that on some areas (diameter ca 3 mm) the test material had adhered to the skin. Complete removal could not be done w
Gross pathology:
Examination at necropsy of the animals did not reveal distinct treatment related gross alterations.

Any other information on results incl. tables

Table 1 - Individual observations

Acute dermal toxicity of Flue Dust T (REACH) in rats; individual and mean body weights, dose amounts applied, and mortality

 

Animal

no.

Dose (ml)

applied1

Body weights (g) recorded on day:

Mortal­ity2

 

0

3

7

14

 

2000 mg/kg

Males

1.24

248

264

284

318

-

1.27

254

269

292

333

-

1.26

253

263

283

315

-

1.24

248

256

271

306

-

10

1.15

230

242

260

293

-

Mean body weight

247

259

278

313

0/5

 

Females

1

0.90

179

180

183

194

-

3

0.88

177

178

192

200

-

5

0.92

183

186

189

199

-

7

0.83

166

171

190

196

-

9

0.86

173

174

190

192

-

Mean body weight

176

178

189

196

0/5

 

1     2000 mg/kg: dose of 5 ml/kg body weight of a 400 mg/ml aqueous dilution of the test substance

3 - = animal survived; + = animal died

 

Table 2– Dermal reactions

Skin irritation scores of Flue Dust T (REACH) after a single 24‑hour dermal exposure in rats

 

 

Males

Animal no.

 

Study day:

             1                            3                            7                            14

 

A-B

A-B

A-B

A-B

2

41-1

42-2

1-0

0-0

4

41-1

43-2

44-0

0-0

6

41-1

43-2

44-0

0-0

8

41-1

43-2

44-0

0-0

10

41-1

42-2

1-0

0-0

 

1=   very slight erythema and wounds (erythema score = 4)

2=   slight erythema in combination with very slight incrustation (erythema score = 4)

3=   moderate erythema in combination with moderate or severe (animal no. 4) incrustation (erythema score = 4)

4=   very slight erythema in combination with slight (animal no. 8), moderate (animal no. 6) or severe (animal no. 4) incrustation (erythema score = 4)

 

 

 

 Females

Animal no.

 

Study day:

             1                            3                            7                            14

 

A-B

A-B

A-B

A-B

1

41-1

42-3

44-0

0-0

3

41-1

42-3

45-0

0-0

5

41-1

43-2

44-0

0-0

7

41-1

43-2

45-0

0-0

9

41-1

42-2

45-0

0-0

 

1=   very slight erythema and wounds (erythema score = 4)

2=   moderate erythema in combination with moderate incrustation (erythema score = 4)

3=   moderate erythema in combination with slight incrustation (erythema score = 4)

4=   very slight erythema in combination with slight incrustation (erythema score = 4)

5=   very slight erythema in combination with very slight incrustation (erythema score = 4)

 

A = erythema (including ischemia, haemorrhages and incrustation); B = oedema

 

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Since all animals survived the 2000 mg/kg dose level, the dermal LD50 of Flue Dust T (REACH) is considered to be higher than 2000 mg/kg body weight. Applying the EC/GHS-classification criteria Flue Dust T (REACH) is considered to be not classified.
Executive summary:

1.        A sample of Flue Dust T (REACH) was examined for acute dermal toxicity in an experiment with male and female rats (limit testing)­, according EEC Directive 96/54/EEC, method B.3 and OECD Guideline no. 402. A dose level of 2000 mg per kg body weight was examined and the dermal contact period was 24 hours.

 

2.        No mortality or clinical signs were observed after treatment with a 2000 mg/kg b.w. dose level. Dermal effects observed generally consisted of slight to moderate erythema, very slight to severe incrustation and slight to moderate oedema. Macro­scopic examination of the surviving animals at the end of the observation period did not reveal any treat­ment‑related gross changes.

 

3.          Since all animals survived the 2000 mg/kg dose level, the dermal LD50of Flue Dust T (REACH) is considered to be higher than 2000 mg/kg body weight. Applying the EC/GHS-classification criteria Flue Dust T (REACH) is considered to be not classified.