4-chlorophenol

Endpoint summary

Description of key information

Acute toxicity: via oral route
The LD50 was determined to be 261 mg/kg bw (EHC, 1989). 
Acute toxicity: via dermal route
The LD50 was determined to be 1500 mg/kg bw (ECHA disseminated dossier, Joint submission, 2012).
Acute toxicity: via inhalation route
The LC50 of the test substance was as 11 mg/m3 (RIVM, 1989).

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:

1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from WHO report on chlorophenols (collective views of an international group of experts)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

oral: unspecified

Vehicle:

not specified

Control animals:

no

Sex:

not specified

Dose descriptor:

LD50

Effect level:

261 mg/kg bw

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

261 mg/kg bw

Quality of whole database:

Estimated Klimisch rating: 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1964

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data from review article (report on chlorophenols - systematic review and critical evaluation of relevant data).

Principles of method if other than guideline:

The study was conducted before a guideline was available. No further data are on-hand.

GLP compliance:

no

Remarks:

prior to GLP

Test type:

standard acute method

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

inhalation: vapour

Type of inhalation exposure:

not specified

Analytical verification of test atmosphere concentrations:

not specified

Sex:

not specified

Dose descriptor:

LC50

Effect level:

11 mg/m³ air

Based on:

test mat.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LC50

Value:

11 mg/m³ air

Quality of whole database:

Estimated Klimisch rating: 2

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 500 mg/kg bw

Additional information

Acute toxicity

Based on the results of a reliable study performed by NIOSH/USA and listed in EHC (1989), the acute oral lethal dose (LD50) of the test substance in rat is 261 mg/kg bw. The study is equivalent/similar to OECD Guidance 401.

Further results for the test substance are available which also supports the findings presented above (see table).

 

Result	Species	Test substance	Reference
LD50 260 -1400 mg/kg bw	rat	4-chlorophenol	RIVM, 1991
LD50 1258 mg/kg bw	rat (male)	4-chlorophenol	ECHA Dossier, 2012
LD50 988 mg/kg bw	rat (female)	4-chlorophenol	ECHA Dossier, 2012
LD50 1422 mg/kg bw	mouse (male)	4-chlorophenol	EHC, 1989
LD50 1373 mg/kg bw	mouse (female)	4-chlorophenol	EHC, 1989

 

Concerning acute toxicity studies for dermal exposure in animals available data is listed below:

The acute dermal toxicity of the test substance was examined in a study according to the method of Noakes and Sanderson (Brit. J. Ind. Med. 26, 59, 1969). Wistar rats of (5 m/f) were dermally exposed to a 50% preparation, resulting in a dosage of 1000, 2500 and 5000 mg/kg bw Animals were then observed for mortality and for clinical symptoms of toxicity for 14 days. All animals were subjected to gross necropsy. Nor mortality neither clinical signs of toxicity were observed. No substance-related findings were revealed at necropsy. The LD50 was deemed as > 5000 mg/kg bw (ECHA disseminated dossier, Joint submission, 2012). Furthermore, an acute dermal study was conducted in rats (Gingell et al., 2001). As LD50 a value of 1500 mg/kg bw is reported (ECHA disseminated dossier, Joint submission, 2012).

 

With regard to acute inhalation toxicity, a weight-of-evidence approach is used to evaluate the test substance. Based on the results of a study performed in 1964 and listed in RIVM (1991), the acute lethal concentration (LC50) of the test substance (4-chlorophenol) in rat is 11 mg/m³ air; no further details are provided (Klimisch rating score: 4). With reference to data of the ECHA disseminated Dossier (2012), the acute lethal concentration (LC50) of the test substance in rat is specified as 750 mg/L air. Further data are not available.

Justification for selection of acute toxicity – inhalation endpoint
Weight of evidence

Justification for selection of acute toxicity – dermal endpoint
Data originated from: ECHA disseminated dossier, Joint submission (2012)

Justification for classification or non-classification

Based on the available results regarded as relevant for acute oral toxicity (LD50 rat = 261 mg/kg bw), acute dermal toxicity (LD50 rat = 1500 mg/kg bw) and acute inhalation toxicity (LC50 11 mg/m³), the test substance is classified as follows:

 

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is considered to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014 as follows: acute toxicity: cat. 3, H301, toxic if swallowed; cat. 4, H312, harmful in contact with skin; cat. 4, H332, harmful if inhaled.

 

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG as follows: Xn; R20/21/22 Harmful by inhalation, in contact with skin and if swallowed.