Registration Dossier

Administrative data

Description of key information

The substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (NAF-AO) [EC no. 701-299-7] (see Chap. 1) shows low oral, dermal, and inhalation acute toxicity. Discriminating doses (oral studies) were determined to be 2000 mg/kg bw (no mortality observed). Application of the substance as aerosol at a concentration of 5.14 mg/L did not result in any mortality (LC50 > 5000 mg/m³). The LD50 obtained in an acute dermal toxicity study was > 2000 mg/kg bw. Combined results indicate that NAF-AO is of low acute toxicity independent of the application route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul. - 14 Aug. 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
only female animals under study
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares L 100; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 24106
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen/Germany
- Age at study initiation: young adult
- Weight at study initiation: 165 - 209 g
- Fasting period before study: overnight
- Housing: cages
- Diet: ad libitum, except 3 - 4 h after treatment
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g/10 mL
- Amount of vehicle (if gavage): ~8 mL/kg bw
- Justification for choice of vehicle: miscible with the TS
- Lot/batch no. (if required): 066K0057 (Sigma Chemicals Co.)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7, and 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
diarrhoea in 2/6 animals after 1 - 2 days post-application
Body weight:
normal
Gross pathology:
no particular findings
Other findings:
none
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
The test material 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (technical product L 100) did not cause any mortality in an acute oral toxicity test (OECD 423, acute toxic class method) at the limit concentration of 2000 mg/kg bw. The LC50 was determined to be > 2000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jul. - 14 Aug. 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
yes
Remarks:
only female animals under study
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares L 800; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 21633
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen/Germany
- Age at study initiation: young adult
- Weight at study initiation: 165 - 211 g
- Fasting period before study: overnight
- Housing: cages
- Diet: ad libitum, except 3 - 4 h after treatment
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12


Route of administration:
oral: gavage
Vehicle:
cotton seed oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2 g/10 mL
- Amount of vehicle (if gavage): ~8 mL/kg bw
- Justification for choice of vehicle: miscible with the TS
- Lot/batch no. (if required): 066K0057 (Sigma Chemicals Co.)

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (female)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 0, 7, and 14 d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
not applicable
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
Diarrhoea in 5/6 animals after 1 - 2 days post-application, slight loss of weight and delayed weight gain in 1/6 animals
Body weight:
normal
Gross pathology:
no particular findings
Other findings:
none
Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
The test material 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (technical product L 800) did not cause any mortality in an acute oral toxicity test (OECD 423, acute toxic class method) at the limit concentration of 2000 mg/kg bw. The LC50 was determined to be > 2000 mg/kg bw.
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Pre-guideline, pre-GLP study, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
pre-guideline study
Deviations:
yes
Remarks:
dose
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Produkt-Nr.: 161 001 (additional name: Cumaron-Inden Harz B1 flüssig) (early technical product of the substance 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised')
- no further information
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Schering AG, Berlin
- Age at study initiation: unknown
- Weight at study initiation: males, 110 -120 g, females , 100-115 g
- Fasting period before study: 16 hours
- Housing: conventional in air-conditioned room, 5 animals per cage
- Diet: Ssniff (Pellets)
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): unknown
- Air changes (per hr): unknown
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED
- Test group: 16 mL/kg bw
- Control group: 40 mL/kg bw
Doses:
Test group: 16 mL/kg bw test item
Control group: 40 mL/kg 0.5% aqueous CMC (carboxymethyl cellulose)
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: unknown
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight
Statistics:
None
Preliminary study:
None
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 16 mL/kg bw
Based on:
test mat.
Remarks on result:
other: the dose applied was ca. 14,000 to 16,000 mg/kg bw based on a density of the test material of about 1 to 1.1 g/cm³
Mortality:
In the test group 2/5 males and 1/5 females died. No deaths were noted in the control group.
Clinical signs:
shaggy fur, hunched posture, pallor of the extremities, increased lacrimation, mild to moderate lethargy and ataxia.
Body weight:
On day 14 of observation, body weights were within the normal range, compared with the control group.
Gross pathology:
Moderate to severe hyperaemia of the lungs, slight hyperaemia of the liver, point-like, haemorrhagic erosions in the gastric mucosa, moderate hyperaemia of the duodenal mucosa with bloody intestinal contents.
Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is of low acute oral toxicity potential.
Executive summary:

In this study, the test substance was given to 10 animals at a concentration of 16 mL/kg bw. Out of the 10 animals, 3 died as a result of the treatment. The 14 day observation period revealed that there were some signs of toxicity in the test group. However as the dose is 8 times the OECD recommend limit dose, this is to be expected. As such, no futher testing would be required.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
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:
02 - 16 Dec. 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Qualifier:
according to
Guideline:
EU Method B.2 (Acute Toxicity (Inhalation))
GLP compliance:
yes (incl. certificate)
Test type:
traditional method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares TL 10; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 28724
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Ltd, Oxon, UK
- Age at study initiation: 8 - 12 wks
- Weight at study initiation: 267 - 310 g (m); 197 - 210 (f) [see Appendix 6]
- Fasting period before study: no
- Housing: solid-floor polypropylene cages, groups of 5 by sex
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: ≥ 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25
- Humidity (%): 30 - 70
- Air changes (per hr): ≥ 15x/h
- Photoperiod (hrs dark / hrs light): 12 / 12


Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: diethyl ether
Mass median aerodynamic diameter (MMAD):
2.38 µm
Geometric standard deviation (GSD):
2.37
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Cylindrical exposure chamber
- Exposure chamber volume: approx. 30 litres (dimensions: 28 cm diameter x 50 cm high)
- Method of holding animals in test chamber: individually held in a tapered, polycarbonate restraining tube
- Method of conditioning air: Compressed air supplied by means of an oil free compressor and passed through a water trap and respiratory quality filters before it was introduced to the nebuliser.
- Air flow through chamber: 50 L/min
- System of generating particulates/aerosols: Glass concentric jet nebuliser located at the top of the exposure chamber / Nebuliser connected to a glass syringe attached to an infusion pump providing the material formulation
- Method of particle size determination: 3x during the exposure, using a Marple Personal Cascade Impactor with six impactor stages (9.0, 6.3, 4.0, 1.7, 0.81, and 0.30 µm cut points). The collection substrates and backup filter were weighed before and after sampling and the weight of test material, collected at each stage, calculated by difference (Results in Report Fig. 3 and 4).
- Method of particle collection: by weighed glass fibre filter placed in a filter holder and temporarily sealed in a vacant port of the exposure chamber in the animals’ breathing zone.
- Volatile / non-volatile fraction: The mean non-volatile component of the batch used during the study was found to be 100% (n=10).
- Procedure: Prior to the start of the study, the non-volatile component of the test material was determined by adding a small, known amount of test material to glass fibre filters and recording their weights. The filters were then dried in a desiccator between 19 and 20 °C for approx. 24 h and then weighed again. The difference in the two weights was taken as the volatile content of the test material and the non-volatile component was calculated as a percentage.
- Treatment of exhaust air: bottom outlet through a "scrubber" trap, connected with a high efficiency filter to a metered exhaust system
- Temperature, humidity, pressure in air chamber: 19 - 20 °C, 39 - 47% (rel.hum.), slight low-pressure [Report, Appendix 9]

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

VEHICLE
- Composition of vehicle (if applicable): diethyl ether
- Concentration of test material in vehicle (if applicable): 50 % (w/w)
- Justification of choice of vehicle: high viscosity of the TS, to improve aerolisation of the TS

TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 72.7% < 4 µm
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 2.38 µm

Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetrically (aerosol)
Duration of exposure:
4 h
Concentrations:
Mean: 5.14 ± 0.64 mg/L (n = 17) / nominal: 16.1 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: day 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other:
Statistics:
For particle size: arithmetic mean + standard deviation / MMAD derived from probits of stage amounts plotted against Log10 cut-point size + geometric standard deviation / LD50: not relevant
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 5.14 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Key result
Sex:
male/female
Dose descriptor:
LC0
Effect level:
5.14 mg/L air (analytical)
Based on:
test mat.
Exp. duration:
4 h
Remarks on result:
other: standard deviation: 0.64 mg/L
Mortality:
none
Clinical signs:
Hunched posture, pilo-erection, and increased respiratory rate commonly seen for short periods following 4h inhalation.
One day after exposure, all animals appeared normal.
Body weight:
One male with bw transiently reduced during week 1;
Normal bodyweight development was noted for all other animals during the course of the study [see Report Appendix 6].
Gross pathology:
No macroscopic abnormalities

The particle size analysis of the atmosphere drawn from the animals’ breathing zone, was as follows

[see Report Appendices 1 and 2]:

 

Mean Achieved Atmosphere
Concentration
± SD (n = 17) [mg/L]

Mean Mass Median
Aerodynamic Diameter (n = 3) [µm]

Geometric Standard Deviation
[mm]

Inhalable Fraction
[wt% < 4 µm]

5.14 ± 0.64

2.38

2.37

72.7

 

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
No classification required according to Regulation (EC) 1272/2008 (CLP regulation)
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
5 000 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:
19 Oct. – 05 Nov. 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
- Name of test material (as cited in study report): Novares TL 10; CAS-no. 71302-83-5 (Hydrocarbons, C9- unsaturated, polymerized)
- Composition of test material, percentage of components: see Section 1.2 Composition
- Lot/batch No.: 28724
- Stability under test conditions: no measured data; based on chemical structure assumed to be stable
- Storage condition of test material: room temperature, exclusion of light
Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic
- Age at study initiation: no data, adult
- Weight at study initiation: 289 - 345 g (m); 203 - 238 g (f);
- Fasting period before study: no
- Housing: 1 animal/plastic cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12


Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: about 6 x 6 cm
- % coverage: aprox. 10% of the body surface
- Type of wrap if used: mull and plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water
- Time after start of exposure: 24 h


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
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:
Body weight: before application, 8th and 15th day of study
Mortality: daily
Clinical signs: daily
Pathological examination: 15th day of study
- Necropsy of survivors performed: yes
Statistics:
not applicable
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Key result
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Mortality:
none
Clinical signs:
after 3 h: piloerection in 9/10 animals, single cases with decreased response to stimuli;
after 2 d: no particular findings
Body weight:
males: normal
females: transient decrease in body weight or decreased increments in weight gain from day 0-8 in 2/5 and 3/5 animals, respectively, normal at day 15 in all animals
Gross pathology:
no particular findings

Table No. 1: Individual body weight of animals – 2000 mg/kg – males

Animal No.

Before application

8th day

15th day

Body weight gain (g)

day 0-8 day
p.a.

day 8-15
p.a.

1 (pre-test)

303.12

314.82

344.33

11.70

29.51

2

312.22

319.95

339.75

7.73

19.80

3

288.64

307.12

322.93

18.48

15.81

4

331.10

343.42

372.79

12.32

29.37

5

345.85

356.79

382.47

10.94

25.68

Average

316.19

328.42

352.45

12.23

24.03

Table No. 2: Individual body weight of animals – 2000 mg/kg – females

Animal No.

Before application

8th day

15th day

Body weight gain (g)

day 0-8
p.a.

day 8-15
p.a.

1 (pre-test)

202.76

198.41

218.00

-4.35

19.59

2

211.57

215.53

226.80

3.96

11.27

3

237.63

238.23

244.08

0.6

5.85

4

203.10

205.58

214.33

2.48

8.75

5

226.60

215.68

230.24

-10.92

14.56

Average

216.33

214.69

226.69

-1.65

12.00

The test substance, Novares TL 10, applied on skin at a dose 2000 mg/kg of animal weight did not cause death of animals.    

Clinical signs of intoxication (piloerection, decreased response to stimuli) were observed in all males and four females. Transient decreases in body weight of females were recorded during study. No macroscopic changes were diagnosed during pathological examination of the animals.

Interpretation of results:
Category 5 based on GHS criteria
Remarks:
according to Regulation (EC) 1272/2008 (CLP regulation) no classification required
Conclusions:
The test material 'Naphtha (petroleum), steam-cracked, C8-10 aromatic hydrocarbon fraction, alkylated and oligomerised' (technical product TL 10) did not cause any mortality in an acute dermal toxicity test (OECD 402) at the limit concentration of 2000 mg/kg bw. The LC50 was determined to be > 2000 mg/kg bw.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

The substance NAF-AO is produced under variable conditions resulting in different technical products of the substance. Several of these products have been tested for acute toxicity.

Acute oral toxicity

Two GLP compliant studies according to OECD TG 423 (acute toxic class method) have been conducted on the acute oral toxicity endpoint using two technical products of NAF-AO (Novares L 100 and L 800). No mortality was observed in either study. The discriminating dose was determined to be > 2000 mg/kg bw (LD0 = 2000 mg/kg bw).

In an early pre-guideline, pre-GLP study, the former technical product of NAF-AO (product 161001, Cumaron-Inden Harz B1 flüssig) was examined in an acute oral toxicity study similar to OECD TG 401 carried out as limit test. At a test concentration of 16 mL/kg bw, a mortality of 3 out of 10 animals (30 %) was observed. The test concentration corresponds to a dose of ca. 14,000 to 16,000 mg/kg bw. The LD50 was determined to be > 16 mL/kg bw. With this concentration, the limit value of OECD test guidelines (2000 mg/kg bw) is exceeded 7 to 8 fold.

The overwhelming weight of evidence suggests that the substance NAF-AO is not likely to be acutely toxic via the oral route.

Acute dermal toxicity

A GLP compliant study (OECD 402) has been conducted on the acute dermal toxicity endpoint using NAF-AO in form of its technical product Novares TL 10.

No deaths were recorded. As such it can be concluded that the hydrocarbon mixture has a low acute dermal toxic potential. The LD50 in the study was greater than 2000 mg/kg bw, and no significant treatment related toxicities were seen.

Acute inhalation toxicity

A GLP compliant study was conducted using NAF-AO (technical product Novares TL 10) as an aerosol via the inhalation route. More than 70% of the aerosol was respirable (MMAD < 4 µm). No animal deaths were observed during the study. The LC50 was greater than 5.14 mg/L. No significant toxicity was noted.

Overall, the acute toxicity of the substance NAF-AO in its different forms is very low. No mortality was observed in limit tests according to OECD TG for the oral, the dermal, and the inhalation route. Only at a very high oral dose in an old pre-GLP, pre-guideline test in the range of 15,000 mg/kg bw, 30% mortality was observed. Limit values are exceeded manifold in this test. This low percentage of dead animals confirms the low acute toxicity of the substance NAF-AO.

Justification for classification or non-classification

Since both, acute oral and dermal toxicity values are greater than 2000 mg/kg bw and the acute inhalation toxicity value is above 5 mg/L, classification according to Regulation (EC) No 1272/2008 (CLP regulation) is not required.