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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
17 February - 28 October 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant, guideline study, no restrictions, fully adequate for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
430-550-0
EC Name:
-
Cas Number:
1671-49-4
Molecular formula:
C8H9NO4S
IUPAC Name:
4-methanesulfonyl-1-methyl-2-nitrobenzene
Details on test material:
- Physical state: off-white powder
- Purity test date: 25 July 2005
- Expiration date of the lot/batch: July 2006
- Storage condition of test material: <30°C

Test animals

Species:
rat
Strain:
other: Alpk:APfSD (Wistar-derived)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 345±16.6 g (males), 240.8±12.3 g (females)
- Fasting period before study: none
- Housing: 5 per cage, sexes separately in cages suitable for rats of this strain and weight range expected during the course of the study
- Diet: RMI ad libitum (except during exposure)
- Water: mains water ad libitum (except during exposure)
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Humidity: 30-70%
- Air changes: minimum of 15 per hr
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 14 October 2005 To: 28 October 2005

Administration / exposure

Route of administration:
inhalation
Type of inhalation exposure:
nose only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: PERSPEX exposure chamber covered with an aluminium cone and standing on an aluminium base
- Exposure chamber volume: approximately 9.2 L (in this study 2 chambers were connected giving a total chamber volume of approximately 27.6 L)
- Method of holding animals in test chamber: polycarbonate restraining tubes
- Source and rate of air: clean, dried and filtered air, at least 10 air-changes per hour. Flow rates 20 L/min.
- System of generating particulates/aerosols: Rotating Brush Generator (RBG)
- Method of particle size determination: Marple Cascade Impactor
- Temperature, humidity, pressure in air chamber: 21.2-21.3°C; 5-7%, slightly higher than ambient

TEST ATMOSPHERE
- Brief description of analytical method used: HPLC
- Samples taken from breathing zone: yes

Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
5 mg/L
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed prior to study start, frequently during exposure, at end of exposure period and once per day thereafter. Weighed prior to study start (day -1), days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: none
Statistics:
None (limit test, no mortalities)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.41 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: limit test, no mortalities
Mortality:
none
Clinical signs:
other: During exposure, abnormalities generally associated with restraint (wet fur and chromodacryorrhea) were seen and all animals had substance around the snout. Immediately after exposure wet fur, salivation, stains around the nose and chromodacryorrhea were
Body weight:
All animals gained weight by day 8 and continued to gain weight until the end of the study.
Gross pathology:
No abnormalities were seen.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Nose-only exposure for 4 hours to a particulate concentration of 5.41 mg/L of the test substance resulted in no deaths and no adverse effects. The acute inhalation LC50 is in excess of 5.41 mg/L.
Executive summary:

A group of 5 male and 5 female Alpk:APfSD (Wistar-derived) rats were exposed nose-only for a single 4-hour period to the test substance at a target particulate concentration of 5 mg/L. Test atmospheres were analysed for particulate concentration and the test substance. Following exposure, the animals were retained for 14 days without treatment. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period the animals were killed and subjected to a gross examination post mortem. The achieved test atmosphere had the following characteristics: achieved particulate concentration = 5.41 mg/L; MMAD 7.02 and 6.06 µm; GSD 1.77 and 1.74. Nose-only exposure for 4-hours to a particulate concentration of 5.41 mg/L resulted in no deaths and no adverse effects. The acute inhalation LC50is in excess of 5.41 mg/L.