Registration Dossier

Administrative data

Description of key information

Oral (OECD 401), rat: 4147 mg/kg bw (males and females)

Inhalation (OECD 403), rat: 2.5 mg/L (males and females)

Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (males and females)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 Jun - 12 Jul 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted in 1987
Deviations:
no
GLP compliance:
no
Test type:
other: acute oral toxicity
Limit test:
no
Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Age at study initiation: about 40 days
- Weight at study initiation: 118 - 206 g (males), 120 - 164 g (females)
- Housing: 5 animals of the same sex per cage in high density polypropylene cages (56 x 38 x 18 cm) with stainless steel grid floors and top
- Diet: Laboratory Diet No. 1, pelleted (K and K Greeff Chemicals Ltd.), ad libitum (except for the removal of food approximately 18 h before rats were given the test material by gavage)
- Water: tap water, ad libitum
- Acclimation period: at least seven days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (18 - 25 acceptable limits)
- Humidity (%): 55 (40 - 65 acceptable limits)
- Air changes (per hr): approximately 17
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
oral: gavage
Vehicle:
maize oil
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
Doses:
1500, 2500, 3150, 3969 and 5000 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: Animals were observed at least at three separate inspections during the first hour after administration and twice daily after Day 2. Inspection for decedents was conducted three times daily and two times at weekends. Individual bodyweights were determined on the day before dosing and on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Acute median lethal dose, 95% confidence interval and slope of the dose response curve for both sexes was determined by probit analysis. When probit analysis failed to demonstrate a linear dosage/mortality response curve, the LD50 and 95% confidence interval were calculated using the method of moving average interpolation after Thompson.
Sex:
male
Dose descriptor:
LD50
Effect level:
4 462 mg/kg bw
Based on:
test mat.
95% CL:
>= 4 383 - <= 4 545
Sex:
female
Dose descriptor:
LD50
Effect level:
3 852 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 128 - <= 4 838
Sex:
male/female
Dose descriptor:
LD50
Effect level:
4 147 mg/kg bw
Based on:
test mat.
95% CL:
>= 3 783 - <= 4 608
Mortality:
1500 and 2000 mg/kg bw: no mortalities occured
3150 mg/kg bw: 1/5 female died (at 1 - 3 day post dose)
3969 mg/kg bw: 1/5 male died (at 1 - 5 day post dose) and 2/5 females died (at 1 - 3 day and 1 - 4 day post dose)
5000 mg/kg bw: 4/5 males died (at 2 - 2 day and 2 - 3 day post dose) and 5/5 females died (at 1 - 2 day, 2 - 3 day, 1 - 4 day post dose)
Clinical signs:
1500 mg/kg bw: ungroomed appearance (Day 2)
2500 mg/kg bw: ungroomed appearance (Day 2)
3150 mg/kg bw: diarrhoe, hunched posture and decreased motor activity (between 30 min and 1 h post dose); ungroomed appearance (Day 2)
3969 mg/kg bw: diarrhoe, hunched posture and decreased motor activity (between 30 min and 1 h post dose); ungroomed appearance (Day 2)
5000 mg/kg bw: diarrhoe, hunched posture and decreased motor activity (between 30 min and 1 h post dose); transient periods of irritability and hyperpnoea (during 30 min post dose in occasional decedents); ungroomed appearance and pigmented staining of the snout (Day 2)

All surviving animals at 2500 mg/kg bw or more continued to show ungroomed appearance for varying length of time up to Day 7. Several animals amongst the higher treatment groups also displayed pigmented staining of the snout until Day 4. Other infrequently observed signs during this period included pigmented orbital secretion and thin body conformation. No abnormality was observed after Day 7.
Body weight:
No effect on body weight was noted.
Gross pathology:
Necropsy of decedents revealed abnormal gastrointestinal contents in the majority of animals. Superficial staining of the mouth, nares, forelimbs, head, urogenital area or general body surfaces was also observed in many animals. Other less frequently noticed gross pathological findings included congestion or haemorrhage of the thymus, slight congestion or incomplete collapse of the lungs and congestion of the brain.
Necropsy of survivors revealed fibrous adhesions between the stomach and adjacent tissues of the left lobe of the liver and abdominal wall in 4 males and one female treated with 3969 mg/kg bw. A low incidence of gastrointestinal contents, slight or moderate hydronephrosis and slight congestion of the lungs was observed in rats of the lower dose groups.

Table 1: Results of acute oral toxicity testing

Males

Dose [mg/kg bw]

Toxicological results*

Duration of signs

Time of death

Mortality (%)

1500

0/5/5

Day 2

-

0

2500

0/5/5

4 h - Day 3

-

0

3150

0/5/5

1 h - Day 7

-

0

3969

1/5/5

1 h - Day 8

Day 5

20

5000

4/5/5

15 min - Day 5

Day 2

80

LD50= 4462 mg/kg bw

Females

1500

0/5/5

Day 2

-

0

2500

0/5/5

4 h - Day 3

-

0

3150

1/5/5

1 h - Day 8

Day 4

20

3969

2/5/5

1 h - Day 8

Day 3

40

5000

5/5/5

15 min - death

Day 1-2

100

LD50= 3852 mg/kg bw

* number of dead animals/number of animals with signs of toxicity/total number of animals tested

Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
4 147 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable guideline study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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:
19 Jul - 5 Aug 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Version / remarks:
adopted in 2009
Deviations:
no
GLP compliance:
no
Test type:
traditional method
Limit test:
no
Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Weight at study initiation: 182 - 224 g (males), 199 - 223 g (females)
- Housing: 5 animals of the same sex per cage in high density polypropylene cages (56 x 38 x 18 cm) with stainless steel grid floors and top
- Diet: Spratt´s Laboratory Diet No. 1, pelleted (K and K Greeff Chemicals Ltd.), ad libitum (except for the removal of food approximately 18 h before the test substance was administered)
- Water: tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (18 - 25 acceptable limits)
- Humidity (%): 55 (40 - 65 acceptable limits)
- Air changes (per hr): approximately 17
- Photoperiod (hrs dark / hrs light): 12 / 12
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
other: isopropanol
Mass median aerodynamic diameter (MMAD):
>= 4 - <= 5.1 µm
Geometric standard deviation (GSD):
>= 2.5 - <= 2.8
Remark on MMAD/GSD:
The particle size analysis of the isopropanol aerosol (vehicle) proved impracticable because of excessive evaporation.
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: exposure chamber with a 30 cm diameter aluminium alloy cylinder
- Exposure chamber volume: ca. 60 L
- Method of holding animals in test chamber: individual polycarbonate restraining holder
- Source and rate of air: Dry oil-free compressed air was pressed through the annular jet of the atomiser at a pressure of ca. 10 psi giving an air-flow of ca. 20 L/min.
- System of generating particulates/aerosols: Test atmospheres were generated using controlled fluid feed from a motorized syringe (Sage syringe pump, model 355, from Arnold R. Horwell Limited, London, England) to a glass concentric jet atomiser mounted into the top of the chamber.
- Method of particle size determination: The aerosol was characterised using a cascade impactor (Model MKIIa, from C.F. Casella and Company Limited, London) ahich was located into a vacant animal exposure port. The particle size distribution was determined using the ECD (Effective Cut-off Diameter) method of bulk estimation, the mass recovered at each stage being determined by the weight gain of the sampling discs.
- Treatment of exhaust air: Exhaust air was passed through mineral oil, a glass cyclone separator, an activitated carbon "scrubber" and a pair of absolute filters arranged in series before being vented to atmosphere via the pump.
- Temperature, humidity, pressure in air chamber: Target temperature and humidity in the exposure chamber were 22 ± 3 °C and 40 - 60%, respectively.

TEST ATMOSPHERE
- Brief description of analytical method used: The total aerosol concentration was determined by drawing a continous atmosphere sample through an absolute filter located in the chamber wall at a flow rate of 2 L/min. The fractional concentrations of chlorophen and isopropanol were subsequently determined by passing dry air through the absolute filters for a minimum of two hours to remove the isopropanol by evaporation. In addition, the vapour concentration of isopropanol was determined by further passing the above air samples through a trap containing approximately 10 g of activated charcoal to absorb isopropanol.

VEHICLE
- Concentration of test material in vehicle: 75% (w/w)

TEST ATMOSPHERE
Please refer to Table 1 under "Any other information on materials and methods incl. tables".
Analytical verification of test atmosphere concentrations:
yes
Remarks:
gravimetric
Duration of exposure:
4 h
Concentrations:
15.5, 20.4 and 24.5 mg/L (nominal concentration for the test material)
11.6, 15.3 and 18.4 mg/L (nominal concentration for the active ingredient)
2.07, 2.40 and 3.13 mg/L (actual concentration for the active ingredient)
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: During exposure, animals were observed in 15 min intervals for the first hour and at 30 min intervals for the remainder of the exposure period. After exposure, animals were observed at 30 min intervals for the first 3 hours. Subsequently, animals were observed twice daily until study termination. Animals were weighed daily on the first 5 days and on Days 8, 11, and 15 (day of termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights (liver, kidneys and lungs)
Sex:
male
Dose descriptor:
LC50
Effect level:
2.6 mg/L air
Based on:
act. ingr.
95% CL:
>= 1.92 - <= 3.52
Exp. duration:
4 h
Sex:
female
Dose descriptor:
LC50
Effect level:
2.43 mg/L air
Based on:
act. ingr.
95% CL:
>= 2.03 - <= 2.9
Exp. duration:
4 h
Sex:
male/female
Dose descriptor:
LC50
Effect level:
2.5 mg/L air
Based on:
act. ingr.
95% CL:
>= 2.13 - <= 2.93
Exp. duration:
4 h
Mortality:
2.07 mg/L: 1/5 male died during exposure and 1/5 female died on Day 2 after exposure
2.40 mg/L: 3/5 males and 3/5 females died during exposure
3.13 mg/L: 2/5 males and 3/5 females died during exposure, 1/5 male died 30 min after exposure and 1/5 female died on Day 2 after exposure
Clinical signs:
other: 2.07, 2.40 and 3.13 mg/L: displayed bradypnoea and hyperpnoea during exposure in all animals (apparent within 45 min of commencement of treatment until death or throughout the whole exposure period); decreased motor activity, ataxia, bradypnoea, gasping,
Body weight:
2.07, 2.40 and 3.13 mg/L: Body weight gains of surviving rats were considerably below expectation and were considered to reflect a clear effect of treatment with the test compound. There was, however, a trend to partial recovery towards the end of the recovery period.
Gross pathology:
2.07, 2.40 and 3.13 mg/L: externally localised or general surface staining of the coat in all decedents; incomplete collapse and congestion of the lungs, firm lungs and aerated fluid in the trachea together with gaseous and fluid stomach and intestinal content in decedents; three cases of hydronephrosis, four cases of enlarged cervical lymph nodes and a single hepatic nodule in decedents; distention of the stomach and intestinal tract and enlarged mesenteric lymph nodes in one surviving female of the highest exposure group; isolated hydronephrosis, pulmonary congestion or petechiae and a liver nodule in single surviving animals (not clearly treatment-related).
Other findings:
- Organ weights: increased lung weights consistent with pulmonary irritation and oedema in decedents (indication of acute respiratory failure due to oedema).

Table 2: Results of acute inhalation toxicity testing

chlorophene concentration [mg/L air]

Toxicological results*

Onset of clinical signs

Time of death

Mortality
[%]

Males

0.0

0/2/5

180 min

0

0

2.07

1/5/5

30 min

2.7 h during exposure

20

2.40

3/5/5

30 min

2.6-4.0 h during exposure

60

3.13

3/5/5

10 min

2.2 h during exposure– 0.5 h after exposure

60

LC50= 2.60 mg/L air

 

Females

0.0

0/1/5

210 min

0

0

2.07

1/5/5

45 min

Day 2 after exposure

20

2.40

3/5/5

30 min

1.8-3.7 h during exposure

60

3.13

4/5/5

15 min

1.7 h during exposure–
Day 2 after exposure

60

LC50= 2.43 mg/L air

 

* number of dead animals/number of animals with signs of toxicity/total number of animals tested

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
CLP: Acute Tox. 4, H332
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LC50
Value:
2 500 mg/m³
Quality of whole database:
The available information comprises an adequate and reliable guideline study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

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:
27 Jun - 11 Jul 1983
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
no purity provided
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 1981
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Version / remarks:
adopted in 2017
Deviations:
yes
Remarks:
directly 5 animals tested instead of single animals in a sequential manner with two animals used at any selected dose level in the main study
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CD
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (U.K.) Limited
- Age at study initiation: about 10 weeks
- Weight at study initiation: 258 - 306 g (males), 179 - 210 g (females)
- Housing: 5 animals of the same sex per cage in high density polypropylene cages (56 x 38 x 18 cm) with stainless steel grid floors and top
- Diet: Laboratory Diet No. 1, pelleted (K and K Greeff Chemicals Ltd.), ad libitum (except for the removal of food approximately 18 h before the test substance was administered)
- Water: tap water, ad libitum
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 °C (18 - 25 °C acceptable limits)
- Humidity (%): 55% (40 - 65 % acceptable limits)
- Air changes (per hr): approximately 17
- Photoperiod (hrs dark / hrs light): 12 / 12
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsum
- Type of wrap if used: The test material was held in contact with the skin with aluminium foil which was kept in place and protected by a bandage of waterproof plaster wrapped twice around the trunk of the body with sufficient tension to ensure the dose remained securely in place and in contact with the skin.

REMOVAL OF TEST SUBSTANCE
- Washing: The dermal test sites were cleaned by wiping with a wet paper towel.
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: The dose was applied as a thin layer covering the shaven dorsum moistened with 0.2 mL distilled water.
- For solids, paste formed: yes
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at least at three separate inspections during the first hour after administration and twice daily after Day 2. A separate record of responses at the dermal test site was made daily from Day 2. Inspection for decedents was conducted three times daily and two times at weekends. Individual bodyweights were determined on the day before dosing and on Days 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Body weight:
Body weight gains of the majority of animals were within the normal ranges in males and females during the whole study period.
Gross pathology:
Necropsy revealed no substance-related findings.
Other findings:
- Other observations: Occluded application of the test substance caused discolouration of the treated skin, loss of elasticity from the second or third day after dosing and complete loss of dermal flexibility from Day 8. Intact skin was revealed by the slough of a dark, hard inflexible layer from the dermal test site which began on Day 10 and was completed by one-half of the animals before termination. At necropsy small areas of encrustation or ulceration associated with incomplete slough of eschar-like material from the treatment site were observed.
Interpretation of results:
other: CLP/GHS criteria not met; no classification required according to Regulation (EC) No. 1272/2008
Conclusions:
CLP: not classified
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The available information comprises an adequate and reliable guideline study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.

Additional information

Reliable studies regarding acute oral and dermal toxicity are available for the test substance.

 

Oral:

A study for acute oral toxicity in the rat was conducted with the test substance.

Five male and 5 female CD rats per group received 1500, 2500, 3150, 3969 or 5000 mg/kg bw as a solution in maize oil by single-dose oral gavage. In-life observations were made at least thrice during the first hour after dosing and twice each day thereafter throughout the two-week observation period. Surviving animals were weighed before treatment, and on Days 1, 8, and 15. The test was terminated on Day 15. Gross pathological examinations were performed on all animals.

Deaths occurred in females of the three highest dose groups and in males of the two highest dose groups.

The clinical signs observed were increased diarrhoea, hunched posture, and decreased motor activity. These signs occurred in the three highest dose groups between one-half hour and one hour after dosage. On Day 2, ungroomed appearance was observed in the majority of animals from all treated groups.

Necropsy of decedents revealed abnormal gastrointestinal contents in the majority of animals. Superficial staining of the mouth, nares, forelimbs, head, urogenital area or general body surfaces was also observed in many animals. Other less frequently noticed gross pathological findings included congestion or haemorrhage of the thymus, slight congestion or incomplete collapse of the lungs and congestion of the brain.

Necropsy of survivors revealed fibrous adhesions between the stomach and adjacent tissues of the left lobe of the liver and abdominal wall in 4 males and one female treated with 3969 mg/kg bw. A low incidence of gastrointestinal contents, slight or moderate hydronephrosis and slight congestion of the lungs was observed in rats of the lower dose groups.

The LD50 of the test substance is 4462 and 3852 mg/kg bw for males and females, respectively. The LD50 for both sexes is 4147 mg/kg bw.

 

Inhalation:

Five male and five female CD rats per group were nose-only exposed for four hours to an aerosol of the test substance using 2-propanol as a vehicle. Concentrations of 2.07 – 3.13 mg chlorophene/L air were achieved. Analysis of the aerosol particle-size distribution demonstrated that ca. 40% by weight were smaller than 5 µm.

Animals were observed for 14 days post exposure after which they were subjected to detailed necropsy and organ weight analysis.

All test substance-exposed groups showed bradypnoea and hyperpnoea during exposure. A total of twelve animals died during exposure.

After exposure, clinical signs included decreased motor activity, hunched posture, ataxia, bradypnoea, hyperpnoea, gasping, piloerection, ungroomed appearance, pigmented orbital secretion, pigmented staining of the snout, respiratory rales, corneal opacity, bloated abdomen and nasal secretions. Occasionally, diarrhoea and periorbital hair loss were observed. One male died within half an hour after exposure and two females during the first overnight period. There were no additional signs ante mortem for these three animals. Signs became less frequent during the second week. Corneal opacity was the only sign not to have fully resolved by Day 15.

Body weight gains of survivors exposed to the test substance were considerably lower than those of the vehicle controls.

Necropsy of decedents frequently revealed incomplete collapse and congestion of the lungs, firm lungs and aerated fluid in the trachea together with gaseous and fluid stomach and intestinal content. Three cases of hydronephrosis, four cases of enlarged cervical lymph nodes and a single hepatic nodule were observed.

Necropsy of survivors revealed distention of the stomach and intestinal tract and enlarged mesenteric lymph nodes in one female of the highest exposure group. Isolated, not clearly treatment-related, observations included hydronephrosis, pulmonary congestion or petechiae and a liver nodule in single test substance-exposed animals.

Increased lung weights consistent with pulmonary irritation and oedema were noted in decedents. The magnitude of the effect indicates acute respiratory failure due to oedema. Kidney and liver weights were within expected ranges. No effects on organ weights were noted in survivors.

The 4-h LC50 is 2.6 and 2.43 mg/L air for males and females, respectively. The 4-h LC50 for both sexes is 2.5 mg/L air.

 

Dermal:

The test substancewas applied dermally to groups of male and female CD rats. Five rats per sex received a single dermal dose of 2000 mg/kg bw test substance. The test substance was applied occlusively to the shaved skin of the animals. The dressing was removed after 24 h and residual test substance was removed with paper towels moistened with tap water. The animals were inspected at least thrice in the first hour post application and twice daily after Day 2 during the 14-day observation period for mortality, moribundity and clinical signs of toxicity. The animals were weighed individually on the day before dosing and on Days 1, 8 and 15. A complete gross necropsy was performed on all animals of the study. There were no mortalities or signs of toxicity. Animals appeared to have normal weight gain and revealed no conspicuous findings at necropsy.The LD50 of the test substance is > 2000 mg/kg bw for males and females.

Justification for classification or non-classification

The available data on acute oral and dermal toxicity do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.

According to Regulation (EC) 1272/2008 the test substance is classified as Acute Toxic Category 4 (inhalation), H332: Harmful if inhaled.

In fact, this is further in line with the conclusion of the ECHA Committee for Risk Assessment (RAC) Opinion for harmonised EU classification and labelling of Chlorophene based on the same reliable data, which was adopted in 2015 ( RAC CLH-O-0000001412-86-58/F, 12 March 2015). As a result, and referring to the Adaptation to Technical Progress (ATP) to CLP Regulation, Chlorophene was inserted in ATP10 with following classification and labelling for acute toxicity: Acute Tox. 4, H332.