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EC number: 248-326-4 | CAS number: 27213-90-7
Repeated dose toxicity: inhalation
Administrative data
- 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)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 412 (Subacute Inhalation Toxicity: 28-Day Study)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium diisobutylnaphthalenesulphonate
- EC Number:
- 248-326-4
- EC Name:
- Sodium diisobutylnaphthalenesulphonate
- Cas Number:
- 27213-90-7
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- sodium 2,3-bis(2-methylpropyl)naphthalene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- 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
Doses / concentrations
- 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
Results and discussion
Effect levels
- 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
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
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
Applicant's summary and conclusion
- 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.
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