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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Step 1: 01 September 1998 to 14 September 1998 / Step 2: 08 September 1998 to 21 September 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-amino-2,4,6-triiodobenzoic acid
EC Number:
221-493-0
EC Name:
3-amino-2,4,6-triiodobenzoic acid
Cas Number:
3119-15-1
Molecular formula:
C7H4I3NO2
IUPAC Name:
3-amino-2,4,6-triiodobenzoic acid
Test material form:
solid: bulk
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Dr. Schenk, Schering AG, WBK, Berqkamen, Germany, Batch no: 37055008

Test animals

Species:
rat
Strain:
other: WIST (SPF)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Schering AG
- Females (if applicable) nulliparous and non-pregnant: not reported
- Age at study initiation: not reported
- Weight at study initiation: males: 271-284 g, females: 241-269 g
- Fasting period before study: not reported
- Housing: conventional
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7/8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23°C
- Humidity (%): 48-58%
- Photoperiod (hrs dark / hrs light): 12h/12h

IN-LIFE DATES:
Step I :01 Sep.98 to 14 Sep. 98
Step II: 08 Sep. 98 to 21 Sep. 98

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Remarks:
0.9 g NaCl ad 100 ml bidest. water
Details on dermal exposure:
not reported
Duration of exposure:
24 hours
Doses:
Step I:
568.0 mg test substance + 0.6 ml vehicle
541.9 mg test substance + 0.55 ml vehicle
550.2 mg test substance + 0.55 ml vehicle

Step II:
482.0mg test substance + 0.55 ml vehicle
538.1 mg test substance + 0.55 ml vehicle
525.9 mg test substance + 0.55 ml vehicle
No. of animals per sex per dose:
Step I: Male
568.0 mg test substance + 0.6 ml vehicle
541.9 mg test substance + 0.55 ml vehicle
550.2 mg test substance + 0.55 ml vehicle

Step II: Female
482.0mg test substance + 0.55ml vehicle
538.1 mg test substance + 0.55 ml vehicle
525.9 mg test substance + 0.55 ml vehicle
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No animal died in the course of the test.
Clinical signs:
After administration of 2000 mg ZK 2218/kg no compound-related clinical findings were observed.
Body weight:
The body weight gain observed on days 7 and 14 (end of the study) of the test was within the normal range for male and female rats of the age and strain which are routinely used in our laboratory.
Gross pathology:
Autopsy revealed no compound-related findings.

Applicant's summary and conclusion

Conclusions:
The LD50 of the test substance in male and female rats after a single dermal application is > 2000 mg/kg body weight.
Executive summary:

The LD50 of the test substance in male and female rats after a single dermal application is > 2000 mg/kg body weight.