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EC number: 427-440-1 | CAS number: 24487-91-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 1996 - 20 February 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan 59 NohSan Notification No. 4200
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 427-440-1
- EC Name:
- -
- Cas Number:
- 24487-91-0
- Molecular formula:
- C9H9ClO2
- IUPAC Name:
- 2-Methyl-3-methoxy benzoyl chloride
- Test material form:
- other: solid
- Details on test material:
- MMBC
Appearance: tan-yellow solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Kingston, Stone Ridge, NY.
- Age at study initiation: Adult. Males were approximately 55 days old and the females were approximately 65 days old at the time they were dosed.
- Weight at study initiation: The fasted body weights ranged from 197 - 219 g for males and from 184 - 225 g for females.
- Fasting period before study: Overnight.
- Housing: The animals were individually housed in suspended stainless steel cages (7 x 13.5 x 8 in., i.e. 18 x 34 x 20 cm) with wire mesh fronts and bottoms. Cages were suspended above absorbent-paper pan liners which were changed 3 times a week.
- Diet (e.g. ad libitum): PMI Certified Rodent Diet 5002(C) (Purina Mills Inc., Richmond, IN).
- Water (e.g. ad libitum): Free access to filtered tap water (via automatic watering).
- Acclimation period: Approximately one week.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 41 - 49 %
- Photoperiod (hrs dark / hrs light): The light cycle was automatically controlled, 12 hrs on and 12 hrs off.
IN-LIFE DATES: From: To: 6 February 1996 - 20 February 1996
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test substance was dosed in a corn oil suspensions at a constant volume of 10 mL/kg body weight.
The test substance was melted in an oven at 60°C. Corn oil (warmed to 40°C) was added to the appropriate volume and a suspension was attained using a magnetic stir plate and a stir bar. The suspension (kept stirring while dosing) was administered to male and female rats at 500, 2000, and 5000 mg/kg. Dose was calculated from nominal values with no adjustment made for percent active ingredient. All animals were dosed within 1 hour of preparation of the suspensions. Samples were collected after dose administration and submitted for subsequent analytical verification of the target concentration. - Doses:
- 500, 2000 and 5000 mg/kg
- No. of animals per sex per dose:
- 6 males and 6 females per dose.
- Control animals:
- no
- Details on study design:
- OBSERVATIONS AND DETERMINATIONS
All animals were observed for signs of ill health, or reaction to treatment at 1, 2 and 4 hrs after dosing and once daily thereafter for 14 days. Body weights were recorded on day 0 (prior to dosing) and on days 7 and 14. Body weights were determined for found-dead animals when they survived beyond the day of treatment. Decedents were necropsied as death occurred. Surviving rats were killed on day 14 and necropsied.
Necropsy consisted of a gross examination of organs in situ. - Statistics:
- The mortality incidences of males and females were compared across doses with a categorical data modeling procedure using SAS CATMOD (SAS Institute Inc. SAS User's Guide: Statistics, Version 6 Edition, p 405-517. Cary, NC: SAS Institute Inc., 1990). The criterion of statistical significance was 0.05. The LD50 was calculated on the pooled mortality incidences at each dose.
The LD50 and 95% confidence limits were calculated based on the binomial distribution.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 162 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 000 - 5 000
- Remarks on result:
- other: Analysis of the dosing suspensions indicated a 97 - 105 % proximity to target concentration.
- Mortality:
- Dose-related mortality was observed in this study (Table 1). The total mortality incidences (no. deaths/no. treated) for males and females in this study were as follows:
Dose (mg/kg) 500 2000 5000
Males 0/6 0/6 6/6
Females 0/6 0/6 6/6
All animals in the 5000 mg/kg dose group died by day 1.
Since there was not a statistically significant sex-related difference in mortality, the LD50 was calculated from the combined male and female mortality incidence data. - Clinical signs:
- other: Treatment-related clinical signs were observed predominantly at 2000 and 5000 mg/kg and included: diarrhoea, mucus in faeces, scant faeces, passiveness, ataxia, red/tan-stained muzzle, pink-stained dropsheet, brown/yellow-stained analgenital area, lacrima
- Gross pathology:
- No gross changes related to the test substance were observed in survivors at necropsy. One male in the 2000 mg/kg group had a dilated renal pelvis; however, this finding was considered incidental and not related to the test substance.
Necropsy of the decedents revealed liver, spleen and various gastrointestinal changes related to the test substance (Table 2).
Any other information on results incl. tables
Table 1 Mortality and Clinical Signs
Males
Dose (mg/kg) |
Observation |
Hours |
Days |
||
1 |
2 |
4 |
1 - 14 |
||
500 |
No. Alive |
6 |
6 |
6 |
6 |
No. Dead |
0 |
0 |
0 |
0 |
|
Normal |
5 |
5 |
5 |
6 |
|
Analgenital area (brown-stained) |
1 |
1 |
0 |
0 |
|
Diarrhoea |
1 |
1 |
1 |
0 |
|
Faeces: contain mucus |
1 |
1 |
1 |
0 |
|
2000 |
No. Alive |
6 |
6 |
6 |
6 |
No. Dead |
0 |
0 |
0 |
0 |
|
Normal |
5 |
6 |
3 |
6 |
|
Diarrhoea |
1 |
0 |
3 |
0 |
|
5000 |
No. Alive |
3 |
6 |
2 |
0 |
No. Dead |
0 |
0 |
4 |
6 |
|
Normal |
6 |
0 |
0 |
0 |
|
Passive |
0 |
5 |
1 |
All animals died by Day 1. |
|
Prostrate |
0 |
1 |
0 |
||
Dropsheet (pink-stained) |
1 |
1 |
1 |
Females
Dose (mg/kg) |
Observation |
Hours |
Days |
|||||
1 |
2 |
4 |
1 |
2 |
3 |
4 - 14 |
||
500 |
No. Alive |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
No. Dead |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Normal |
2 |
2 |
3 |
6 |
6 |
6 |
6 |
|
Analgenital area (brown-stained) |
2 |
4 |
2 |
0 |
0 |
0 |
0 |
|
Diarrhoea |
4 |
3 |
3 |
0 |
0 |
0 |
0 |
|
Faeces: contain mucus |
3 |
3 |
2 |
0 |
0 |
0 |
0 |
|
2000 |
No. Alive |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
No. Dead |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Normal |
3 |
4 |
4 |
3 |
4 |
5 |
6 |
|
Diarrhoea |
3 |
2 |
2 |
0 |
0 |
0 |
0 |
|
Faeces: contain mucus |
1 |
2 |
0 |
0 |
0 |
0 |
0 |
|
Faeces: scant |
0 |
0 |
0 |
1 |
2 |
0 |
0 |
|
Lacrimation |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
Passive |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
|
Ataxic |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
|
Muzzle: tan-stained fur |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
|
Muzzle: red-stained fur |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
|
Analgenital area (brown/yellow-stained) |
1 |
2 |
1 |
3 |
1 |
1 |
0 |
|
5000 |
No. Alive |
6 |
5 |
2 |
0 |
- |
- |
- |
No. Dead |
0 |
1 |
4 |
6 |
- |
- |
- |
|
Normal |
4 |
0 |
0 |
0 |
- |
- |
- |
|
Passive |
2 |
4 |
0 |
All animals died by Day 1. |
||||
Prostrate |
0 |
1 |
0 |
|||||
Dropsheet (pink-stained) |
0 |
1 |
0 |
|||||
Ataxic |
0 |
1 |
0 |
|||||
Moribund |
0 |
0 |
2 |
Table 2 Necropsy Observations
Males
Dose (mg/kg) |
500 |
2000 |
5000 |
|||
S |
D |
S |
D |
S |
D |
|
No. of Animals |
6 |
0 |
6 |
0 |
0 |
6 |
No. Gross Changes |
6 |
a |
5 |
a |
b |
0 |
Observations |
||||||
Intestines (reddened) |
0 |
a |
0 |
a |
b |
1 |
Liver (brown area on left lobe) |
0 |
a |
0 |
a |
b |
3 |
Stomach (distended) |
0 |
a |
0 |
a |
b |
4 |
Stomach (contains black fluid/material) |
0 |
a |
0 |
a |
b |
6 |
Stomach (black material adhered to mucosa) |
0 |
a |
0 |
a |
b |
6 |
Kidney (right dilated renal pelvis) |
0 |
a |
1 |
a |
b |
0 |
S - Survivors
D - Decedents
a - No observations located in this column because there were no decedents.
b - No observations located in this column because there were no survivors.
Females
Dose (mg/kg) |
500 |
2000 |
5000 |
|||
S |
D |
S |
D |
S |
D |
|
No. of Animals |
6 |
0 |
6 |
0 |
0 |
6 |
No Gross Changes |
6 |
a |
6 |
a |
b |
0 |
Observations |
||||||
Intestines (reddened) |
0 |
a |
0 |
a |
b |
1 |
Liver (brown area on left lobe) |
0 |
a |
0 |
a |
b |
1 |
Spleen (darkened) |
|
|
|
|
|
3 |
Stomach (distended) |
0 |
a |
0 |
a |
b |
3 |
Stomach (contains black fluid) |
0 |
a |
0 |
a |
b |
6 |
Stomach (black material adhered to mucosa) |
0 |
a |
0 |
a |
b |
6 |
S - Survivors
D - Decedents
a - No observations located in this column because there were no decedents.
b - No observations located in this column because there were no survivors.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral LD50 in male and female rats (combined) was 3162 mg/kg, with upper and lower 95% confidence limits of 2000 and 5000 mg/kg, respectively.
- Executive summary:
The acute oral toxicity of the test substance was determined in accordance with standardised guidelines OECD 401, US EPA OPPTS 798.1175 and Japan 59 NohSan Notification No. 4200. During the study groups of 6 males and 6 females received a single administration of test substance, orally by gavage, at dose levels of 500, 2000 or 5000 mg/kg bodyweight and were assessed daily for the following 14 days for any signs of systemic toxicity. Under the conditions of the study, there was 100% mortality within 24 hours post-dosing for all animals treated at 5000 mg/kg. No deaths occurred in either sex at 500 and 2000 mg/kg. Treatment-related clinical signs were observed predominantly at 2000 and 5000 mg/kg and included: diarrhoea, mucus in faeces, scant faeces, passiveness, ataxia, red/tan-stained muzzle, pink-stained dropsheet, brown/yellow-stained analgenital area and lacrimation. A slight decrease in body weight gain was noted in males at 500 mg/kg and 2000 mg/kg; however, no body weight effects were noted in females in either dose group. Necropsy of the decendents revealed gastrointestinal, spleen and liver changes related to the test substance. Since there was not a statistically significant sex-related difference in mortality, the LD50 was calculated from the combined male and female mortality incidence data. The acute oral LD50 in male and female rats (combined) was 3162 mg/kg, with upper and lower 95% confidence limits of 2000 and 5000 mg/kg.
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