Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug. 1983
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
GLP compliance:
not specified
Test type:
standard acute method
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
not applicable
chromium(3+) trisodium bis(2-(2-{4-hydroxy-2-oxido-3-[2-(5-sulfonatonaphthalen-1-yl)diazen-1-yl]phenyl}diazen-1-yl)benzoate)
Test material form:
solid: particulate/powder

Test animals

Details on test animals or test system and environmental conditions:
- Source: Charles River (UK) Ltd., Manston Road, Margate, Kent, England
- Females: nulliparous and non-pregnant
- Age at study initiation: 7 to 8 weeks
- Weight at study initiation: 210 to 300 g
- Fasting period before study: overnight
- Housing: individually for initial 24 hours, then in groups of 5 by gender; solid floor polypropylene boxes with a bedding of softwood sawdust (Sawdust Marketing Company, Standon, Herts), replaced twice weekly
- Diet: ad libitum; SQC Rat and Mouse Maintenance Diet No.1, Expanded (Special Diets Services, Ltd., Stepfield, Witham, Essex, England)
- Water: ad libitum; mains water dispensed from glass water bottles (analytical test report demonstrates suitability)
- Acclimation period: 8 days

- Temperature: 19 to 22 °C
- Humidity: 42 to 70 %
- Air changes per hour: not specified
- Photoperiod (hrs dark / hrs light): 12/12

- One day prior to testing, back and flanks of each animal were clipped free of hair using electric clippers

- individually, using a system of indelible ink marking on the tail (Inscribe 700, Inscribe Ltd., Alton, Hants, England)

- Species: the Sprague-Dawley rat is the species and strain of choice as it is a readily availbale rodent species acceptable to regulatory authorities with documented susceptibility to a wide range of toxic substances following dermal application.
- Stability: there was no information to indicate that the stability of the test item would be adversely affected under the proposed conditions of administration.
- Route tested: the dermal route of administration is a possible route of acute exposure in man during its manufacture, handling or use.

Administration / exposure

Type of coverage:
Details on dermal exposure:
- Area of exposure: dorsal area
- % coverage: approximately 10 %
- Type of wrap used: 75 mm x 125 mm (Sleek, Smith & Nephew, Welwyn Garden City, Herts, England)
- Preparation: shaved with electric clippers 24 hours before treatment

- Washing: wiped clean with disposable towel
- Time after start of exposure: 24 hours

- Amount applied: 4 ml/kg
- Concentration: 500 mg/ml
- Constant volume or concentration used: no
- For solids, paste formed: yes
Duration of exposure:
24 hours
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
Details on study design:
- Duration of observation period following administration: 15 days
- Frequency of observations: 1 and 4 hours after testing then once daily for 14 days
- Frequency of weighing: days 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: overt signs of toxicity; behavioural changes
No statistical test indicated

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality occurred during the study period.
Clinical signs:
other: No abnormal clinical signs wereobserved during the study period.
Gross pathology:
No gross pathological abnormalities were noted at necropsy

Any other information on results incl. tables

Table 1: Mortalities and signs of reaction in rats administered a single dermal application of the test item.

Group number Dose level (mg/kg) Signs of reaction No. showing effects on dosing day (hour) Number showing effects during day of observation Total mortality
1 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14
1 2000 normal 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 10 0/10
death 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0

Table 2: Individual body weights of male and female test animals.

Group number  Dose level (mg/kg) Animal number Body weight on:
Day of dosing Day 7 Day 14 Increment
1 2000 1 300 348 370 70
2 295 374 379 84
3 290 330 356 66
4 300 339 378 78
5 290 327 417 127
6 240 247 244 4
7 237 243 246 9
8 210 219 207 -3
9 245 259 266 21
10 230 251 237 7

Table 3: Individual necropsy findings.

Group number Dose level (mg/kg) Animal number and gender Necropsy
1 2000 1M 2M 3M 4M 5M 6F 7F 8F 9F 10F no abnormalities detected

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC 1272/2008)
The LD50 (dermal, rat) of the test item was found to be greater than 2000 mg/kg bw
Executive summary:

The acute dermal toxicity of the test item was evaluated in an experimental procedure similar to OECD Guideline 402 (1981). 5 male and 5 female Sprague-Dawley rats were administered 2000 mg test item/kg bw (500 mg test item/ml water) by dermal application for 24 hours to a shaved, dorsal region using an occlusive bandage, after which the area was wiped clean with water. Animals were then monitored for mortality, clinical symptoms and body weight changes for 15 days. At the end of the study period, all remaining animals were sacrificed and subjected to gross pathological examination at necropsy.

No mortality or clinical signs were observed during the study period. One animal demonstrated weight loss of 3 g from start to end of the study period, all other animals showed comparable body weight gain at termination. No gross pathological abnormalities were observed at necropsy. Based on these findings, the acute dermal toxicity of the test item in rats of both sexes, observed over a period of 15 days, is estimated to be: greater than 2000 mg/kg bw. Therefore, it can be extrapolated that the LD50 is greater than 2000 mg/kg bw.