Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data available
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study is sufficiently documented. Guideline study (OECD); test substance purity ca. 70%.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
sodium diisobutylnaphtalene sulfonate
Cas Number:
91078-64-7
IUPAC Name:
sodium diisobutylnaphtalene sulfonate
Test material form:
other: solid
Details on test material:
See confidential details on test material section

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach, Germany
- Age at study initiation: about 8 - 9 weeks
- Weight at study initiation: mean: male = 256 ± 22.2 g; female = 182 ± 15.0 g
- Housing: 5 females/cage and 1 male/cage
- Diet: ad libitum
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
other: dust aerosol
Type of inhalation exposure:
nose/head only
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Head-Nose-Inhalationsystem INA20 (BASF SE)
- Exposure chamber volume: 55 L
- Method of holding animals in test chamber: animals were sitting in a tube
- Rate of air: 1500 L/h
- System of generating particulates/aerosols: Vibrationdispenser for highest dose group and a Brushdispenser for the two other groups

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

TEST ATMOSPHERE
- Particle size distribution: respirable dust: 87%, 77%, 77% for low, mid and high dose group
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.):
1.09 mg/L dose group: MMAD 50% = 3.4 µm / GSD = 2.8
3.49 mg/L dose group: MMAD 50% = 4.5 µm / GSD = 3.2
4.76 mg/L dose group: MMAD 50% = 4.0 µm / GSD = 3.6
Analytical verification of test atmosphere concentrations:
yes
Duration of exposure:
4 h
Concentrations:
1.09, 3.49 and 4.76 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 or 28 days
- Frequency of observations and weighing: Weighing occured on day 7 and on day 14 or on days 7, 14 and 28. Observations were done daily on working days.
- Necropsy of survivors performed: yes
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
4.08 mg/L air (analytical)
Based on:
test mat.
Remarks:
(equivalent to the substance as registered)
95% CL:
3.64 - 4.56
Exp. duration:
4 h
Mortality:
4.76 mg/L: 4/5 males and 5/5 females died within 24 hours
3.49 mg/L: 1/5 males died after 14 days, 2/5 females died after 21 days
1.09 mg/L: no animal died
Clinical signs:
other: during exposition: slight attempt to escape, clear discharge from nose, salivation additionally for groups 4.76 and 3.49 mg/L: accelerated respiration, eyelid closure, irregular and intermittent respiration, reddish discharge from nose after exposition:
Body weight:
Normal body weight gain was seen in lowest dose group. The mid dose group showed reduced body weight gain in the first week after exposure. In the second week they gained weight normally.
Gross pathology:
deceased animals: mid dose group: excessive loss of weight, stomach/intestines empty, filled with gas
high dose group: general congestive hyperemia, lung was filled with blood and edema
sacrificed animals: organs without abnormal detection
Other findings:
no data available

Any other information on results incl. tables

The LC50 value after the 28-day observation period was estimated at 3.82 mg/L.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category IV
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda induced acute toxicity after a single exposure of rat by inhalation (aerosol, 4h). As the LC 50 in males and females is comprised between 1.0 and 5.0 mg/L air, the registered substance is considered as harmful by inhalation and is therefore classified as Acute tox. 4 (H332) according to the Regulation (EC) 1272/2008 and as Xn, R20 according to the Directive 67/548/EEC.
Executive summary:

In an acute inhalation toxicity study according to OECD Guideline 403 (1987), groups of young adult Wistar rats (5/sex) were exposed by inhalation route to the test substance as dust aerosol for 4 hours to head/nose only at concentrations of 1.09, 3.49, or 4.76 mg/L. Animals then were observed for up to 28 days. Deaths did not occur in the low exposure concentration. At the mid dose group one male died on test day 14 (20% mortality) and two females on test day 21 (40%). One male animal survived the exposure with 4.76 mg/L test substance. The mean body weight gain was reduced in the mid dose group in the first week whereas in the second week it was normal again. The low dose group showed normal body weight gain. Slight attempt to escape, clear discharge from nose, salivation were symptoms seen during exposure in any dose group. In the mid and high dose group also following symptoms were seen: accelerated respiration, eyelid closure, irregular and intermittent respiration, reddish discharge from nose. After exposure, bloody smeared snout, salivation, piloerection were noted in animals of the low dose group on the first day after exposure. Bloody discharge from nose, reddish head, accelerated respiration, piloerection, anogenital region smeared with urine, respiratory sounds, reduced general state, reduced defecation, partly expanded abdomen and anemic aspect, high stepping gait, intermittent respiration were noted in animals of the mid dose group. These symptoms were seen until the end of observation. Partly accelerated respiration, blood smeared head, reddish discharge from nose, fur in thorax region reddish soiled, slight reduced general state, piloerection was found in one male from the high dose group. The animal was without symptoms on day 7 after exposure. At necropsy dead animals from high dose group showed general congestive hyperemia and a lung filled with blood and edema. The animals which died from the mid dose group showed excessive loss of weight, empty stomach/intestines, filled with gas. Sacrificed animals showed no abnormal detection at gross pathology.

As derived from the overall study results the acute LC50 values for a 14 -day observation period are: 

LC50 = 4.08 mg/L (95% C.I. 3.64 - 4.56) based on test substance (ca. 70% sodium diisobutylnaphthalenesulphonate).

Under the test conditions, Reaction product of naphthalene, butanol, sulfonated and neutralized by caustic soda induced acute toxicity after a single exposure of rat by inhalation (aerosol, 4h). As the LC 50 in males and females is comprised between 1.0 and 5.0 mg/L air, the registered substance is considered as harmful by inhalation and is therefore classified as Acute tox. 4 (H332) according to the Regulation (EC) 1272/2008 and as Xn, R20 according to the Directive 67/548/EEC.