Registration Dossier
Registration Dossier
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EC number: 248-326-4 | CAS number: 27213-90-7
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- no guideline available
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Duration of treatment / exposure:
- 5-weeks
- Remarks:
- Doses / Concentrations:
100, 500 or 2500 ppm
Basis:
nominal in water - No. of animals per sex per dose:
- 10 male and 10 female rats
- Control animals:
- yes
- Dose descriptor:
- NOAEL
- Effect level:
- 500 ppm
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- body weight and weight gain
- Dose descriptor:
- NOAEL
- Effect level:
- 2 500 ppm
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- behaviour (functional findings)
- body weight and weight gain
- clinical biochemistry
- clinical signs
- food consumption and compound intake
- gross pathology
- haematology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
- water consumption and compound intake
- Critical effects observed:
- not specified
- Conclusions:
- Concentrations of 100 and 500 ppm were therefore well tolerated by males, while concentrations up to 2500 ppm were tolerate without negative effects by female rats.
Reference
Food and water intake, general behaviour and mortality were not affected by treatment. Growth was reduced only in male rats administered 2500 ppm.
Up to 2500 ppm, no damage to blood or organs have been observed.
No liver effects have been observed in clinic, anatomy, pathology and histopathology studies up to 2500 ppm.
No kidney effects have been observed in blood and urine analysis, and histopathological studies.
Glucose and cholesterol concentrations in plasma and sodium, potassium, calcium, inorganic phosphate and chlorine products in serum were in the normal range in all dose groups.
Pathology and anatomy analysis revealed no other damage to other organs related to the test item.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 64.78 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Remarks on MMAD:
- MMAD / GSD: MMAD= 3.1 - 3.3 um
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hours per day; 5 days per week
- Remarks:
- Doses / Concentrations:
0.8, 8, 80 mg/m3
Basis:
nominal conc. - No. of animals per sex per dose:
- 5 male/female rats
- Control animals:
- yes
- Dose descriptor:
- NOEL
- Effect level:
- 0.8 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- Critical effects observed:
- not specified
- Conclusions:
- The test substance induced unspecific toxic effects in the nasal cavity and lungs as known from the inhalation of mild irritants. The lesions are reversible except the increase of connective tissue in the lungs which is seen as a reparative process after the inhalation of a mild irritant.
The no-observed-effect-level (NOEL) under the conditions of the test is 0.8 mg/m3.
Reference
The following findings were obtained and assessed to be related to the inhalation of the test substance:
80 mg/m3 group
main group
Clinical examinations
- retarded body weight change (male rats)
Clinical chemistry and hematology
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights (males and females)
Macroscopic lesions
- no substance-related effects
Microscopic lesions
lungs:
- hypertrophy of goblet cells (male and females)
- interstitial pneumonitis (increased in grading; males and females)
- increased connective tissue content (male and females)
nasal cavity (level 1):
- focal metaplasia of the respiratory epithelium (males and females)
80 mg/m3 group
post-exposure observation group. Females
Clinical examinations
- no substance-related effects
Relative and absolute lung weights
- trend towards increased absolute and relative lung weigths
Macroscopic lesions
- no substance-related effects
Microscopic lesions
- increased connective tissue content lungs
8 mg/m3 group
main group
Clinicalexaminations, clinical chemistry and hematology. macroscopic and microscopic lesions
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights
8 mg/m3 group
post-exposure observation group. females
Clinical examinations. macroscopic and microscopic lesions
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights
0.8 mg/m3 groups:
main and post-exposure observation groups
- no substance-related effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 0.8 mg/m³
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Remarks on MMAD:
- MMAD / GSD: MMAD= 3.1 - 3.3 um
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 6 hours per day; 5 days per week
- Remarks:
- Doses / Concentrations:
0.8, 8, 80 mg/m3
Basis:
nominal conc. - No. of animals per sex per dose:
- 5 male/female rats
- Control animals:
- yes
- Dose descriptor:
- NOEL
- Effect level:
- 0.8 mg/m³ air
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- Critical effects observed:
- not specified
- Conclusions:
- The test substance induced unspecific toxic effects in the nasal cavity and lungs as known from the inhalation of mild irritants. The lesions are reversible except the increase of connective tissue in the lungs which is seen as a reparative process after the inhalation of a mild irritant.
The no-observed-effect-level (NOEL) under the conditions of the test is 0.8 mg/m3.
Reference
The following findings were obtained and assessed to be related to the inhalation of the test substance:
80 mg/m3 group
main group
Clinical examinations
- retarded body weight change (male rats)
Clinical chemistry and hematology
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights (males and females)
Macroscopic lesions
- no substance-related effects
Microscopic lesions
lungs:
- hypertrophy of goblet cells (male and females)
- interstitial pneumonitis (increased in grading; males and females)
- increased connective tissue content (male and females)
nasal cavity (level 1):
- focal metaplasia of the respiratory epithelium (males and females)
80 mg/m3 group
post-exposure observation group. Females
Clinical examinations
- no substance-related effects
Relative and absolute lung weights
- trend towards increased absolute and relative lung weigths
Macroscopic lesions
- no substance-related effects
Microscopic lesions
- increased connective tissue content lungs
8 mg/m3 group
main group
Clinicalexaminations, clinical chemistry and hematology. macroscopic and microscopic lesions
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights
8 mg/m3 group
post-exposure observation group. females
Clinical examinations. macroscopic and microscopic lesions
- no substance-related effects
Relative and absolute organ weights
- increased absolute and relative lung weights
0.8 mg/m3 groups:
main and post-exposure observation groups
- no substance-related effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEC
- 8 mg/m³
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The findings of the repeated toxicity studies by oral and inhalation route reported effects for which a hazard classification is not foreseen.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
The selected study is the only study available for the oral route.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
The selected study is the only study available for the inhalation route.
Justification for selection of repeated dose toxicity inhalation - local effects endpoint:
The selected study is the only study available for the inhalation route.
Justification for classification or non-classification
Basing on the available data and according to Regulation 1272/2008/EC, the substance is not classified for specific target organ toxicity after repeated exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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