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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
November 1998 - January 1999
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
none

Test animals

Species:
other: rat, Wistar Crl:WI BR
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: 35-42 days
- mean body weight at study initiation:
males: 291.8 g +/- 9.8 g, n=5
females: 199.8 g +/- 3.1 g; n=5
- Fasting period before study:
- Housing: Altromin Type S8/15, granulated soft wood bedding
- Diet (ad libitum): Altromin 1326, pelleted standard diet, Batch# 150299/1351
- Water (ad libitum): tap water (municipal supply)
- Acclimation period: 13 days before administration

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22.5°C
- Humidity (%): 45-70%
- Air changes (per hr): air conditioned.
- Photoperiod (hrs dark / hrs light): artificial light was set to give a cycle of 12 our light and 12 hours dark, the light phase was from
6.30 a.m. - 6.30 p.m.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Remarks:
distilled water
Details on dermal exposure:
TEST SITE
- Area of exposure: 6 x 6 cm (trunk)
- Type of wrap if used: covered with aluminium foil (6.5 x 6.5 cm) which was fixed in place with sticking plaster (Lohmann GmbH & Co, Neuwied)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the application area was washed with water
- Time after start of exposure: 24 hours after application

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.2 g test item/ 100 g body weight. Individual doses were adjusted according to body weight on the day of administration

VEHICLE
- Amount(s) applied (volume or weight with unit): the gauze patch was moistened with distilled water
Duration of exposure:
24 h
Doses:
Dose group: 2000 mg/kg body weight (b.w.)
0.2 g of the test article per 100 g body weight were applied
No. of animals per sex per dose:
5 males per dose
5 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality and morbidity continuously on the day of administration and once daily thereafter (in the morning). Animals were also observed for erythema and /or oedema at the skin of the application area one hour after patch removal and once daily thereafter (in the morning). Body weights were recorded on the day of administration and on days 7 and 14.
- Necropsy of survivors performed: At the end of the observation all animals were killed by CO2 inhalation. All animal swree examined externally. The cranial, thoracic and abdominal cavities were then opened and examined marcorscopically.
Statistics:
body weights: Calculation of group mean values and standard deviations.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No animal died during the course of investigation.
Male: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: > 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Clinical observations: No clinical signs were observed during the cours of investigation.
Body weight:
The body weight gain of the male and female animals was in the renage of th historical control data in the test facility.
Gross pathology:
There were no macroscopic pathological findings in the animals.
Other findings:
Skin of the application area: The skin of the application area was not altered.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item is neither a toxic nor a harmful substance according to this acute dermal toxicity study.
Executive summary:

Guidance on information requirements and chemical safety assessment, Chapter R.7a, p.279: Endpoint specific guidance, Guidance for the implementation of REACH, May 2008, ECHA:

Non-testing data can be provided by read-across method.

Important considerations for this read-across approach is:

 ·      BLANCOLEN HP shows very similar physico-chemical properties as BRUGGOLITE FF6

 ·      BLANCOLEN HP is a constituent of BRUGGOLITE FF6

 ·      The structural similarity between the two chemicals.

 ·      The oxidation of sufinate into sulfonate in aqueous solution

 

Acute dermal toxicity of BRUGGOLITE FF6 was tested on five female and five male rats. The test item was applied at a single dose of 2000 mg/kgbwto a shaved dorsal area of the animals’ trunk and then covered with a gauze patch which was held in contact with the skin with an occlusive dressing. Exposure time was 24 h. Then the affected area was washed with water. Animals were examined for mortality, clinical signs, alterations of the application area, body weight gain and pathological alterations of organs at the end of a 14-day observation period. None of the animals died during the course of the investigation. Clinical signs, skin alterations on the application area or pathological findings at necropsy could not be observed. The body weight gain was not affected.

Dermal LD50(rat) > 2000 mg/kgbw