Registration Dossier

Administrative data

Description of key information

Naphthenic acids, zinc salts is not expected to show acute toxic effects via oral, inhalation and dermal route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-09-24 to 1980-10-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
1981-05-12
Deviations:
yes
Remarks:
information on strain of rats, equilibration period, and on time period of observations were missing; rats were not weighed weekly
Principles of method if other than guideline:
It has to be mentioned that no OECD guideline was available at the time of conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS - albino rats
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
- Weight at study initiation: average initial body weight: 210 g (males) and 205 g (females)
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
whole body
Vehicle:
other: mineral spirits and clean air
Details on inhalation exposure:
PREPARATION OF TEST MATERIAL
The material was used as a 50% w/v suspension in mineral spirits

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: the animals were exposed to the test material inside a 260 liter plexiglass exposure chamber.

- System of generating particulates/aerosols: the material was administered as an aerosol which was generated by a six jet Collision nebulizer (BGI Incorporated, Waltham, Mass.). The air was passed through a desicant prior to being passed through the test material. The rate of flow through the chamber was 20 liters per minute (except during particle size measurement) at a temperature of 72°F (22.2°C).

- Method of particle size determination: particle size of the aerosol was determined using an Andersen Sampler cascade impactor. The Andersen Sampler was run for 5 minutes midway through the exposure. During sampling, air from the breathing zone of the animals was drawn through the cascade impactor at the rate of 1 cubic foot per minute (28.3 liters per minute).
The amount of aerosol impacting on each plate of the Andersen Sampler was determined by differential weighing. From these values the mass median diameter of the aerosol was calculated to be 0.54u and the concentration was calculated to be 0.42 mg/liter.

TEST ATMOSPHERE
The average concentration of the aerosol over the four hour exposure period was calculated to be 11.6 mg/liter by differential weighing of the flask from which the aerosol was generated.

Analytical verification of test atmosphere concentrations:
yes
Remarks:
please refer to "details on inhalation exposure" above
Duration of exposure:
4 h
Concentrations:
Actual concentration: 0.42 mg/liter (maximum concentration which could be attained)
Nominal concentration: 11.6 mg/liter
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Examinations performed: Signs of toxicity and mortalities (daily) were noted. The average initial body weight and the average final body weight were determined.
Statistics:
not stated
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 420 mg/m³ air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: the maximum concentration which could be attained
Mortality:
No mortality occurred during the study.
Clinical signs:
other: No untoward symptoms were observed during the four hour exposure period. Within 18 - 24 hours the animals appeared depressed and ruffled. They were essentially normal after 48 hours.
Body weight:
The average body weight of the rats increased during the study.
Gross pathology:
Gross pathological examination revealed nothing remarkable.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LC50 (male and female rats, 4h) > 0.42 mg/liter (analytical)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the inhalation route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the inhalation route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
420 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1980-09-11 to 1980-09-25
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted 1981-05-12
Deviations:
yes
Remarks:
substance was tested on abraded skin; removal of substance was not described; area covered by test substance was not exactly stated; body weight was not determined weekly; information on strain of rabbit was missing
Principles of method if other than guideline:
It has to be mentioned that no OECD guideline was available at the time of conduct.
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS - albino rabbits
- Weight at study initiation: between 2.0 and 3.0 kg; average initial weight: 2.33 kg (males) and 2.27 kg (females)
- Housing: the animals were housed and maintained in compliance with the Animal Welfare Act (Pub. L-94-279) 9 CFR Part 3.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure and type of wrap used: all animals had their backs clipped free of hair 24 hours prior to testing. All of the animals had their backs abraded prior to dosing.
All rabbits were weighed and the correct amount of experimental material was applied to the back of each animal. These treated areas were covered with large gauze patches and an impervious material was wrapped snugly around the trunk of each animal.

REMOVAL OF TEST SUBSTANCE
- Washing: the dressing was removed after the exposure period and any excess material was removed and the approximate amount remaining was noted.
- Time after start of exposure: 24 hours after application of the test material


Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5 males / 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for a 14 day period for signs of toxicity and for mortalities.
- Necropsy of survivors performed: yes
Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period.
Statistics:
not stated
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study.
Clinical signs:
Except for very substantial skin irritation lasting throughout the course of the observation period, no other untoward symptoms were observed.
Body weight:
The average body weight of the rabbits increased during the study.
Gross pathology:
Gross pathologic examination revealed nothing remarkable.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (male and female rabbits; abraded skin) > 2000 mg/kg
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the dermal route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the dermal route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Acute oral toxicity

One key study by Richeux (2006; OECD 423 (2001); GLP compliant) and one supporting study by Anonymous (1980; OECD 401 (1981); GLP complaint) were conducted with naphthenic acids, zinc salts, basic and naphthenic acids, zinc salts, respectively, are used to address this endpoint. The LD50 was determined to be greater than 2000 mg/kg bw for naphthenic acids, zinc salts, basic.

Acute inhalation toxicity

One reliable study by Anonymous (1980; OECD 403 (1981); GLP compliant) was conducted with naphthenic acids, zinc salts is used to address this endpoint. The LC50 was determined to be greater the 420 mg/m3 (analytical; maximum attainable concentration).

Acute dermal toxicity

One reliable study by Anonymous (1980; OECD 402 (1981); GLP compliant) conducted with naphthenic acids, zinc salts is used to address this endpoint. The LD50 was determined to be greater than 2000 mg/kg bw.

Justification for classification or non-classification

The oral and dermal LD50 for naphthenic acids, zinc salts is greater than 2000 mg/kg bw. In addition, the LC50 for acute inhalation toxicity is greater than 420 mg/m3 air (analytical). This was the maximum attainable concentration, which could be tested. Thus, the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral, inhalation and dermal toxicity.