5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 5th Jannuary, 1995 to 19th Jannuary, 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

according to EEC directive 92/69 B3

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride

EC Number:

417-220-1

EC Name:

5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride

Cas Number:

37441-29-5

Molecular formula:

C8H2Cl2I3NO2

IUPAC Name:

5-amino-2,4,6-triiodobenzene-1,3-dicarbonyl dichloride

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Remarks:

Han1bm:Wist (outbred, SPFQuality) .

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rationale for alternative/additional species to rat: Recognised by international guidelines as the recommended test system (e.g. OECD, EEC).
- Source: BRL Ltd., Basel, Switzerland.
- Age at study initiation: Approx. 11 weeks.
- Weight at study initiation: Within ± 20% of the sex mean
- Housing: Individually housed in labelled polycarbonate cages containing purified sawdust as bedding material (Woody SPF, supplied by B.M.I., Helmond, The Netherlands).
- Diet: Free access to standard pelleted laboratory animal diet (Kliba 343 from Klingentalmuhle AG, Kaiseraugst, Switzerland).
- Water: Free access to tap-water.
- Acclimation period: at least 5 days before start of treatment under laboratory conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C
- Humidity (%): 50%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light and 12 hours dark per day.

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Remarks:

Specific gravity 0.92

Details on dermal exposure:

TEST SITE
- Area of exposure: back clipped free of hair
- % coverage: 25 cm2 (5x5 cm) for males and 18 cm2 (3.5~5 cm) for females
- Type of wrap if used: a gauze patch fixed successively to aluminium foil and flexible bandage (Coban, 3M, S t . Paul, U.S.A.), with drops of petrolatum.

REMOVAL OF TEST SUBSTANCE
- Washing: yes
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: Mortality/Viability: twice daily. Body weights: Days 1 (pre-administration), 8 and 15.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: At periodic intervals on the day o f treatment (day 1) and once daily thereafter, until day 15. .

Statistics:

No statistical analysis was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

not specified

Mortality:

No mortality observed.

Clinical signs:

other: Lethargy and/or hunched posture was observed on 2 males on days 2 and 3.

Gross pathology:

None

Other findings:

Yellow discoloration of the treated skin on day 2 in all animals.

Applicant's summary and conclusion

Interpretation of results:

other: not classified as harmful/toxic according to CLP Regulation (EC) 1272/2008

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

The acute dermal toxicity of the test item was evaluated in an experimental study according to OECD Guideline No. 402, "Acute Dermal Toxicityn and EU Method B.3.

The substance was administered to five rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the experimental period (day 15).

No mortality occurred. Lethargy and/or hunched posture were observed in two males on days 2 and 3. Yellow discolouration o f the treated skin area was seen in all animals on day 2.

Body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found in the animals at macroscopic post mortem examination.

The dermal LD50 value of the test item in rats was established as exceeding 2000 mg/kg body weight.