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EC number: 417-220-1 | CAS number: 37441-29-5 ATIPACL
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From January 10th, 1995 to February 10th, 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- acording to EEC directive 92/69 B6 maximization test
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- other: "Allergic Contact Dermatitis in the Guinea-Pig: Identification of Contact Allergensu Magnusson B. Kligman A.M., 1970 published by C.C. Thomas, Springfield, Illinois , USA.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- An LLNA study was not performed because there is an existing reliable study for skin sensitisation using the Guinea Pig Maximisation test method.
Test material
- 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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- (HA)BR albino guinea pig (SPFquality)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females (if applicable) nulliparous and non-pregnant: not specified
- Age at study initiation: Approx. 6-7 weeks
- Weight at study initiation: 376 - 500 grams
- Housing: Group housing of 2 animals, except for 1 control animal, per labelled metal cage with wire-mesh floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1600 mglkg); LC 23-0, pellet diameter 4mm (Hope farms, Woerden, The Netherlands). In addition, hay (B.M.I., Helmond, The Netherlands) was provided once a week.
- Water: Free access to tap water, diluted with decalcif ied water.
- Acclimation period: At least 5 dayes before start of treatment
- Indication of any skin lesions: no
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
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 2.5 % (w/w) intradermal injection
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, open
- Vehicle:
- corn oil
- Concentration / amount:
50% epidermal application
Challenge
- No.:
- #1
- Route:
- epicutaneous, open
- Vehicle:
- corn oil
- Concentration / amount:
0, 10, 25, 50 % (w/w)
- No. of animals per dose:
- Number of animals in test group 10
number of animals in negative control group 5 - Details on study design:
- PRELIMINARY STUDY
Intradermal injections (one animals):
A 5% and 1% test substance concentration were injected in one animal into two injection sites (0.1 ml each) in the left and right clipped.shoulder regions respectively. The resulting dermal reactions were assessed 24 and 48 hours later for erythema , necrosis and diameter of necrosis.
Epidermal-application (the same animal as mentioned before):
A 50% test substance concentration (0.5 m l ) was applied epidermally on a shaved flank of one animal, using a Scotchpak-non-woven patch (2.5 x 2.2 cm) on Micropore tape and held in place by Coban elasticbandage. After 24 hours, the dressings was removed and the skin cleaned of residual test substance. The treated skin was assessed 24 and 48 hours later according to the scale described below.
Epidermal applications (three animals):
Four concentrations o f the test substance (50%, 25%, 10% and 5%, 0.05 ml each) were applied occlusively on a shaved flank of each of the animals using Square chambers, mounted on Micropore tape and held in place by Coban elastic bandage. After 24 hours, the dressings were removed and the skin cleaned of residual tes t substance. The treated sites were assessed 24 and 48 hours later according to the scale described below.
Erythema and eschar formation:
No erythema .............................................................................0
Slight erythema (barely perceptible) ................................................1
Well-defined erythema ................................................................... 2
Moderate erythema ....................................................................... 3
Severe erythema (beet redness) to s l i g h t eschar formation (injuries in depth) ........... 4
Oedena formation:
No oedema ............................................................................... 0
Slight oedema (barely perceptible) ...................................................... 1
Well-defined oedema (edges of area well-defined by definite raising) ................... 2
Moderate oedema (raised approximately 1 millimeter) ...................................... 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure) . 4
MAIN STUDY
A. INDUCTION EXPOSURE
Day 1
Three pairs of intradermal injections (0.1 ml/site) were made in the clipped scapular region as follows:
A) Freunds' Complete Adjuvant (Difco, Detroit, U.S.A.), 50:50 with water for injection (Ferensius AG, Bad Homburg, Germany).
B) A 2.5% test substance concentration corn oil .
C) The test substance, at twice the concentration used in (B), emulsified in a 50:50 mixture of Freunds' Complete Adjuvant.
Note: One of each pair was on each side of the midline and from cranial A) to caudal C).
Day 3
The dermal reactions caused by the intradermal injections were examined in a similar manner as described for the preliminary study.
Day 7
The clipped scapular area was rubbed with 10% sodium-dodecyl-sulfate in vaseline using a spatula. This concentration of SDS provokes a mild inflammatory
reaction.
Day 8
The clipped area between the injection sites was treated with 0.5 ml f a 50% test substance concentration using a Scotchpak-non-woven patch (2 x 4
cm) mounted on Micropore tape and secured with Coban elastic bandage.
Day 10
After 48 hours, the dressings were removed and the skin cleaned of residual test substance. The skin reactions were assessed immediately after bandage
removal.
B. CHALLENGE EXPOSURE
Day 22
All animals were treated epidermally with 0.05 ml of each of a the following test substance concentrations, 50%, 25% and 10% and the vehicle on a clipped and
shaved flank, using Square chambers, attached to Micropore tape and secured with Coban elastic bandage.
Day 23
After approximately 24 hours, the dressings were removed and the skin cleaned of residual test substance and vehicle. The treated sites were
assessed for redness and swelling 24 and 48 hours after removal of the dressings, using the numerical grading system below. After the first
reading, the test sites were shaved with an electric razor.
At the end of the study period all animals were killed by oxygenlcarbon dioxide asphyxiation.
OBSERVATIONS
Mortality/Viability: Twice daily
Toxicity:At least once daily
Body weights: Prior to start and at termination of the study.
INTERPRETATIONS
The results for the experimental animals at the challenge application(s) were compared with the results for the control animals. Positive skin reactions (grade1 or more) were considered signs of sensitisation, provided that such reactions are not observed in the control group. A sensitisation rate (%) was calculated for each concentration as follows: the number of sensitised animals to one concentration in proportion to the total number of animals of the experimental group. The highest sensitisation rate calculated was used to assign a classification according to Kligman (J. Invest . Dermatol. 47, 393-409, 1966).
Sensitisation rate Grade Classification
0-8 I weak
9-28 II mild
29-64 III moderate
65-80 IV strong
81-100 V extreme - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- other: no data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0%
- No. with + reactions:
- 3
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 1
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 5
Any other information on results incl. tables
Preliminary study:
Maximum concentration not causing irritating effects in preliminary test: 50%
Main study - Induction
In the experimental animals, signs of necrosis (diameter between 2 -6 mm) and well defined or moderate erythema was observed after intradermal injection of a 2.5% test substance concentration. Injection of corn oil only resulted in slight or well defined erythema in the control animals. All experimental animals showed slight to well defined erythema after the 48 h occluded epidermal induction exposure. Light brown staining of the treated skin by the test substance was noted. No skin reactions were noted in the control animals after exposure to corn oil.
Main Study - Challenge
In the control group one animal showed discrete or patchy erythema in response to the 25% and 10% test substance concentrations. No skin reactions were evident in the other animal after the challenge exposure.
In the experimental group all ten animals showed skin recations in response to all the three test substance concentrations during the challenge phase. These reactions were characterised by erythema (grade 1 oe 2) and/or scaliness.
Discrete or patchy erythema and/or scaliness was also noted in resposne to corn oil in four experimental animals.
Toxicity symptoms/ Mortality
No mortality occurred and no symptoms of systemic toxicity were observed in the animals of the main study during the study period.
Body weights
The average body weight gain in experiemntal annimals was higher than of the control animals. Non reason can be given for the cause of the difference.
other observations:
The response to corn oil noted in the experimental animals was considered to have happened by accident. Leakage from adjacent treated sites might possibly have occured. Since the control animals received corn oil treatment in the induction phase, sensitisation to corn oil was ruled out, based on the absence of responses in the control group to vehicle.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Conclusions:
- The results lead to a sensitisation rate of 100%, which indicates that the test substance has extreme sensitizing properties in this test applying the rating of allergenicity described by Kligman A.M. (1966).
- Executive summary:
Assessment for Contact Hypersensitivity to test substance in the Albino Guinea Pig (Maximization Test).
The study was carrIed out in accordance with the OECD Guideline No. A06, "Skin Sensitisation", the EU Method B.6, and based on the method described by Magnusson and Kligman, " Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens".
Based on a test substance pretest , corn oil was selected as the most suitable vehicle for the test substance. Test substance concentrations selected for the Main study were based on the results of a preliminary study using four animals.
In the Main study, ten experimental animals were intradermally injected with a 2.5% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with omission of the test substance.
Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50%, 25% and 10% test substance concentration and corn oil .
The skin reactions observed in response to the 50% test substance concentration in all ten experimental animals in the challenge phase were considered indicative of sensitisation, based on the absence of responses in the control animals to this concentration. Furthermore, all experimental animals showed responses to the 25% and 10% concentrations, whereas a response was noted in one control animal.
Taking into acount this difference in frequency it was concluded that the test susbtance had induced contact hypersensitivity in all experimental animals to all three concentrations.
These results lead to a sensitisation rate of 100 per cent, which indicates that the test substance has extreme sensitizing properties in this test applying the rating of allergenicity described by Kligman A.M. (1966).
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