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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
Since February 11,1986 to February 25,1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: EC Directive 84/449 (Official Journal of the European Communities 27, 1984, L 251, 96).
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Constituent 1
Reference substance name:
Acid Brown 188:2 - Similar Substance 01
IUPAC Name:
Acid Brown 188:2 - Similar Substance 01
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source:Winkelmann
- Age at study initiation: males 9 weeks , females 14 weeks
- Weight at study initiation: males 155-170, females 171-178 g.
- Housing:The rats were conventionally housed in cages Makrolon type III with chip wood pellets , 5 rats for each cage
- Fasting period before study:no, the was wasn't available approximately 16 hours before until 4 hours after application
- Diet: Altromin R 1324 ad libitum
- Water : tap water ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C):22 ± 2 ° C
- Humidity (%): 50 ± 10%
- Photoperiod : 12 hours cycle dark/light from 6 AM to 18 CET PM

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle:20 ml / kg
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per single dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:twice a day
- Necropsy of survivors performed:yes with diethyl ether
- Other examinations performed: clinical signs,

Upon application and at the end of the 14-day observation period the surviving animals were weighed individually.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
ca. 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 3 600 mg/kg bw
Based on:
act. ingr.
Mortality:
no mortality observed
Clinical signs:
no signs observed
Body weight:
no data
Gross pathology:
no pathology observed

Applicant's summary and conclusion

Interpretation of results:
other: CLP criteria not met
Conclusions:
LD50 > 5000 mg/kg bw (LD50 > 3600 mg/kg bw based on active ingredient)
Executive summary:

The substance was tested for acute toxicity with oral administration on male and female Wistar rats. The LD50 for male and female rats was greater than 5000 mg / kg body weight. There were no signs of toxicity.