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EC number: 413-010-9 | CAS number: 6613-44-1 DMBC
- 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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 February 1992 - 1 July 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Method described by Draize: Draize J.H., Woodard G.C., & Calvery H.O.: J. Pharmacol. Exp. Therapeut. 8
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 3,5-dimethylbenzoyl chloride
- EC Number:
- 413-010-9
- EC Name:
- 3,5-dimethylbenzoyl chloride
- Cas Number:
- 6613-44-1
- Molecular formula:
- C9H9ClO
- IUPAC Name:
- 3,5-dimethylbenzoyl chloride
- Details on test material:
- 3,5-Dimethylbenzoyl chloride
Appearance: pale yellowish transparent liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese white rabbits (male)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labs (Inc.)
- Weight at study initiation: 2.3 - 2.6 kg
- Diet (e.g. ad libitum): Solid feed for the rabbit (Oriental Yeast Co.) given ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 2 °C
- Humidity (%): 55 ± 6 %
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.25 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 19 days
- Number of animals:
- 6
- Details on study design:
- The day before the test, back hair of rabbits was removed by means of an electric shaver, and the skin intended to be used as the abraded site had the corneum removed by scratching with an 18 gauge injection needle by crossing pattern after sterilization.
Method of application:
0.25 mL of the test substance was applied on the areas (3 cm²) of intact and abraded skin, and the surface was covered with two-layer gauze and fixed as a closed patch with Tegaderm (3 M) and Tubicot #5 (Tokyo Eizai Labs.). Test sample was exposed to the skin for 24 h, and after then the skin region was wiped using gauze wet with water.
Judgement:
After 24-h exposure of the sample to the skin, any change in the skin was judged by the appropriate criteria. The degree of erythema and oedema was evaluated by the Draize criteria, as illustrated below. In addition, necrosis, crust and scar formation at the test site were observed and evaluated by the criteria shown below.
According to the Draize method, crust and scar formation and oedema observed after 24 and 72 h of sample application were scored. The obtained individual score was divided by the score at the judgement (or "4"), and then the average score of 6 rabbits was obtained to give the primary irritation index (P.I.I.).
Observation was continued until all skin symptoms of 6 rabbits were recovered (for 19 days).
Criteria for judgement for primary irritation (according to Draize)
1. Erythema and scar formation
No erythema 0
Very slight erythema 1
Distinct erythema 2
Medium erythema 3
Strong erythema - slight crust formation 4
2. Oedema
No oedema 0
Very slight oedema 1
Slight oedema (swollen and bordered) 2
Medium oedema (approx 1 mm swelling) 3
Severe oedema (more than 1 mm swelling) 4
Criteria for judgement for the skin symptoms
1. Necrosis (judged by area)
No necrosis 0
Less than ¼ 1
¼ - ½ 2
½ - ¾ 3
¾ - 4/4 4
2. Scar (judged by area)
No scar 0
Less than ¼ 1
¼ - ½ 2
½ - ¾ 3
¾ - 4/4 4
3. Eschar
No eschar 0
Fine layered eschar 1
Scale or desquamatous dried eschar 2
Eschar slightly hard to remove 3
Escher difficult to remove and deep damage 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 1.25
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.75
- Max. score:
- 3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 0.75
- Max. score:
- 1
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- ca. 1.5
- Max. score:
- 3
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- ca. 1
- Max. score:
- 2
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- ca. 2.5
- Max. score:
- 10
- Irritant / corrosive response data:
- Results of observation from the end point of 24-h exposure of the test sample on the skin to the end of the test period are shown in Table 1.
After 24 h exposure, the first observation revealed necrotic change, grey-white to brown-yellowish colour, in all 6 rabbits on the intact and abraded skin, and then very slight oedema was observed.
From 48 h to 120 h period after the exposure to the sample, the erythema and oedema of the skin showed aggravation, and distinct medium erythema and slight to medium oedema were observed.
Ulcer formation was observed at the intact and abraded sites in 5 rabbits after 48 to 144 h of the exposure. After 144 h, the surface of the skin began to dry and harden leading to crust. Then during the recovery of the subcutaneous tissue, the surface skin was removed, and erosion was caused in 5 rabbits. Ulcer region was gradually changed to scar, and erosion was healed to form scar, and eventually skin of all 6 rabbits showed healing after 19 days.
According to the evaluation by P.I.I., the irritation score falls into the category of medium irritation, but greyish-white and brownish discolouration, probably due to necrosis was found. Also, ulcer and erosion were present so the test sample was judged to be corrosive.
Any other information on results incl. tables
Table 1 P.I.I. of DMBC
Items of Observation |
Erythema |
Oedema |
Average Score for Individual Rabbits |
||||
Time of Observation |
After 24 h |
After 72 h |
After 24 h |
After 72 h |
|||
No. of Rabbit |
1 |
Intact Abraded |
0 0 |
2 2 |
1 0 |
1 1 |
1.75 |
2 |
Intact Abraded |
0 0 |
3 3 |
1 0 |
3 3 |
3.25 |
|
3 |
Intact Abraded |
0 0 |
2 2 |
1 1 |
2 2 |
2.50 |
|
4 |
Intact Abraded |
0 0 |
3 3 |
0 1 |
3 2 |
3.00 |
|
5 |
Intact Abraded |
0 0 |
2 2 |
1 0 |
2 2 |
2.25 |
|
6 |
Intact Abraded |
0 0 |
2 2 |
0 0 |
3 3 |
2.50 |
|
P.I.I |
2.5 |
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Draize Scale
- Conclusions:
- DMBC was judged to be corrosive.
- Executive summary:
Primary skin irritation tests of 3,5-dimethylbenzoyl chloride were performed by the Draize method using white rabbits (Draize, J.H., Woodard G.C., & Calvery H.O.; J. Pharmacol. Exp. Therapeut. 8).
It was found that after 24 h exposure of the test sample on the skin, colour change to brownish yellow, probably due to necrosis, occurred and was accompanied by ulcerous change and erosion.
Thus, the test sample was judged to be a corrosive material.
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