Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
: only 2 dose levels examined
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material : BMDBM
- Substance type: organic
- Physical state: solid

Test animals

Species:
rat
Strain:
other: Füllinsdorf Albino SPF rats
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Füllinsdorf, Switzerland
- Weight at study initiation: 194-212g
- Acclimation period: 6d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1°C
- Humidity (%): 55±5°C

Administration / exposure

Type of coverage:
occlusive
Vehicle:
other: carbitol
Details on dermal exposure:
TEST SITE
- Area of exposure: dorso-lumbal
- % coverage: approximately 10% of body surface
- Type of wrap if used: gauze, pergamine paper and occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with warm water
- Time after start of exposure: 24h

TEST MATERIAL
- Concentration (if solution): 0, 500, and 1000 mg/kg bw
- For solids, paste formed: yes, at the highest concentration
Duration of exposure:
24h
Doses:
0, 500, and 1000 mg/kg bw
No. of animals per sex per dose:
5 male and 5 female animals per dose group.
Control animals:
yes, concurrent vehicle
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
1 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no deaths at highest dose level 1000 mg/kg bw
Mortality:
No mortalities were recorded during the 14 day observation period.
Clinical signs:
Females: slight (grade 1) to moderate (grade 3) erythema were detected in 4 animals of the control group on days 1 and 4. With 500 mg/kg all 5 animals showed slight erythema on day 4. With 1000 mg/kg only one animal was detected with well defined erythema (grade 2). Edemas were not detected in females.

Males: In all groups neither erythema nor edemas were found throughout the experiment.
Body weight:
Body weight had in all groups decreased during the 24 h of dermal exposure in the occlusive dressing. Further body weight development was normal.
Gross pathology:
At final autopsy 2 males and 1 female of the 1000 mg/kg group were detected with dark spots on one or both kidneys. Histological examination considered them as non-pathological. No further anomalies were found.

Any other information on results incl. tables

Table 1: Bodyweights of male rats dermally treated with butyl methoxydibenzoylmethane.

Day

Bodyweight [g]

0 mg/kg bw

500 mg/kg bw

1000 mg/kg bw

0

208.0±11.9

212.8±5.9

213.6±9.6

1

197.8±14.6

205.2±9.1

209.8±8.3

2

206.0±14.1

214.2±9.9

210.2±11.1

5

225.4±16.3

238.0±13.9

235.8±14.9

6

229.2±19.6

242.0±14.1

240.8±15.4

7

234.8±19.0

246.8±15.3

247.0±17.4

8

238.2±19.2

252.6±16.3

250.6±17.7

14

262.0±24.7

279.6±19.0

273.2±24.7

15

270.6±27.6

287.6±21.5

279.8±25.1

 

Table 2: Bodyweights of female rats dermally treated with butyl methoxydibenzoylmethane.

Day

Bodyweight [g]

0 mg/kg bw

500 mg/kg bw

1000 mg/kg bw

0

198.0±7.1

198.2±8.8

189.8±5.0

1

190.4±8.1

191.2±10.7

184.4±5.0

4

198.4±7.6

2.2.4±10.8

194.0±4.7

5

198.6±8.3

205.6±11.7

195.0±3.4

6

201.6±8.6

07.6±13.6

194.0±2.9

7

203.8±10.6

210.2±13.6

198.8±2.9

8

2.5.6±11.9

210.8±12.7

198.8±5.8

13

212.0±8.4

220.2±14.8

208.0±3.7

15

216.0±11.5

229.0±18.2

212.4±4.3

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Test item BMDBM was applied to rats up maximum to 1000 mg/kg, since the mode of application was limited by the consistence of the suspension with Carbitol. No mortalities reported.
Executive summary:

Suspensions containing 20 % and 40 % butyl methoxydibenzoylmethane (BMDBM) in Carbitol (w/v) were prepared for a single dermal application of 500 and 1000 mg/kg. The sample with maximum dosis had the consistence of a paste. Control groups were treated with Carbitol only.

Except one initial decrease during the day of dermal exposure body weight development during the following 14-day observation period was in all groups normal. No deaths were found. In female groups slight to moderate erythema were detected up to 4 days after exposure. Four cases were from the control group, five from the low dosis group and one from the high dosis group. Except one animal in the control group which was classified as the most severe case (medium erythema) all others were of slight to well defined grade. It can be assumed that Carbitol has an irritative effect on the skin of female rats since frequency and severity of erythema among the 3 groups rather reflect the amount of solvent than the test substance. In all male groups no skin reactions were observed. No edemas were detected neither in male nor female groups. Final autopsy showed no abnormalities, except 3 animals with a few dark spots on kidneys, which after histological examination were not characterized pathological.

Test item BMDBM was applied to rats up maximum to 1000 mg/kg, since the mode of application was limited by the consistence of the suspension with Carbitol. No mortalities reported.