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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline study report

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name: CAVAMAX® W7 Pharma
CAS no.: 7585-39-9
Chemical name: .beta.-Cyclodextrin
Purpose: industrial chemical
Colour: white
Physical state: solid
Storage: protected from light
Stability: water: stable

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
Species/strain: Healthy rats, WISTAR Crl: WI(Han) (Full-Barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female The female animals were nulliparous and non-pregnant.
Body weight at the beginning of the study: females: 200 - 220 g, males 240 – 260 g
Age at the beginning of the study: females: 17 weeks, males: 10 weeks old
Number of animals: 5 male and 5 female
Housing and Feeding Conditions:
Full-barrier in an air-conditioned room
Temperature: 22 3 °C
Relative humidity: 55 10%
Artificial light, sequence being 12 hours light, 12 hours dark
Air change: 10 x / hour
Free access to Altromin 1324 maintenance diet for rats and mice (lot no. 1310)
Adequate acclimatisation period: 8 days
Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological control at regular intervals)
The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 060609)

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
Approximately 24 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. No less than 10% of the body surface was cleared for the application. The test item was applied at a single dose, uniformly over an area which was approx. 10% of the total body surface. The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
other: Other side of skin served as a control
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded. Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.
Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. The animals were weighed on day 1 (prior to the application) and on days 8 and 15
- Necropsy of survivors performed: yes
Statistics:
not reported

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: none
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: none
Mortality:
no mortality was observed
Clinical signs:
Chromodacryorrhea was observed in 2 of 5 female animals and in 1 of 5 male animals.
Body weight:
The body weight development of all male and female animals was within the expected range, except for a slight weight loss in 1 out of 5 female animals. The toxicological relevance of this finding cannot clearly be concluded
Gross pathology:
1 of 5 female animals and 1 of 5 male animals showed a dark discolouration of the right lung.
Other findings:
Scratches were observed in 2 of 5 female. All signs of irritation were reversible within the observation period, except for 1 of 5 female animals.

Applicant's summary and conclusion

Interpretation of results:
relatively harmless
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with mild signs of toxicity, but no mortality.
Executive summary:

Beta cyclodextzrin (98% pure) was assessed for its dermal toxicity in 5 rats of each sex according to OECD Guideline 402. The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner. Under the conditions of the study, single dermal application of the test item to rats at a limit dose of 2000 mg/kg body weight was associated with mild signs of toxicity, but no mortality. Chromodacryorrhea was observed in 2 of 5 female animals and in 1 of 5 male animals. 1 of 5 female animals and 1 of 5 male animals showed a dark discolouration of the right lung. The body weight development of all male and female animals was within the expected range, except for a slight weight loss in 1 out of 5 female animals. Scratches were observed in 2 of 5 female. All signs of irritation were reversible within the observation period, except for 1 of 5 female animals. For acute percutaneous toxicity neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000mg/kg body weight.