2,4-dimethyl-6-(1-methyl-pentadecyl)phenol

Endpoint summary

Description of key information

Acute oral toxicity: LD50 > 2000 mg/kg bw; Ciba-Geigy 1991, OECD Guideline Study
Acute dermal toxicity: LD50 > 2000 mg/kg bw; Ciba-Geigy 1991, OECD Guideline Study

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:

19.09. - 17.10.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD guideline study, GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24. February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: 183 to 200 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Macrolon cages type 4
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.10. to 17.10.1991

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Remarks:

0.5 % (w/v) in 0.1 % (w/v) aqueous polysorbate 80

Details on oral exposure:

Volume applied: 10 mL/kg body weight

Doses:

2000 mg/kg bw (males and females)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed:
Mortality : daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14

Statistics:

Group means and respective standard deviations were calculated of body weights.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred

Mortality:

No mortality occurred in this study.

Clinical signs:

other: Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The oral LD50 value of the test article in rats was established to exceed 2000 mg/kg body weight.

Executive summary:

In an oral toxicity study according to OECD guideline 401, five male and five female Tif: RAIf rats were dosed once with the test article in the vehicle (0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate80) by gastric intubation at a dose level of 2000 mg/kg body weight and observed for 14 days. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortalities were recorded. Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days. At autopsy, no deviations from normal morphology were found. The oral LD50 value of the test article was established to exceed 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

01.10. - 29.10.1991

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: OECD Guideline study, GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

other: Tif:RAIf

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: CIBA-GEIGY Limited, Animal Production, 4332 Stein, Switzerland
- Weight at study initiation: 217 to 248 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- Housing: Macrolon cages type 3
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 55 +/- 10 %
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 01.10. to 17.10.1991

Type of coverage:

semiocclusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: on the back of the animals
- % coverage: 10
- Type of wrap if used: a gauze-lined semiocclusive dressing fastened around the trunk with an adhesive elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the skin was cleaned with lukewarm water.
- Time after start of exposure: 24 hrs

TEST MATERIAL
- Amount applied: 2 mL

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
- Necropsy of survivors performed: yes
- Other examinations performed:
Mortality : daily; a.m. and p.m. on working days, a.m. on weekend days
Signs and symptoms: daily for 14 days
Body weight: immediately before administration and on days 7 and 14

Statistics:

From the body weights, the group means and their standard deviations were calculated.

Preliminary study:

Not applicable.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality occurred.

Mortality:

No mortality occurred in this study.

Clinical signs:

other: Slight piloerection was observed in both, female and male animals. The animals recovered within 2 days.

Gross pathology:

At autopsy, no deviations from normal morphology were found.

Other findings:

None.

Interpretation of results:

practically nontoxic

Remarks:

Migrated information

Conclusions:

The dermal LD50 value of the test article in Wistar rats was established to exceed 2000 mg/kg body weight.

Executive summary:

The acute dermal toxicity of the test substance was assessed in a toxicity study following OECD guideline 402 and in compliance with GLP. The test article was administered to five TIF:RAIf rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortality occurred. Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. At autopsy, no deviations from normal morphology were found. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral

In a GLP-compliant acute oral toxicity study (OECD 401, Ciba-Geigy 1991), the test substance in the vehicle ( 0.5 % (w/v) carboxymethylcellulose in 0.1 % (w/v) aqueous polysorbate 80) was administered by oral gavage to five Tif: RAIf rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortalities were recorded. Piloerection, hunched posture and dyspnea were seen, being common symptoms in acute tests. The animals recovered within 5 days. At autopsy, no deviations from normal morphology were found. The oral LD50 value of the test article was established to exceed 2000 mg/kg body weight.

A supporting study (Ciba-Geigy, 1989) showed similar results.

Dermal

In a GLP-compliant acute dermal toxicity study (OECD 402, Ciba-Geigy 1991) the test article was administered unchanged (no vehicle) to five TIF:RAIf rats of each sex by dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed at the end of the observation period. No mortality occurred. Piloerection was seen, being a common symptom in acute dermal tests. The animals recovered within 2 days. At autopsy, no deviations from normal morphology were found. The dermal LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight.

Justification for selection of acute toxicity – oral endpoint
GLP-compliant guideline study

Justification for selection of acute toxicity – dermal endpoint
GLP-compliant guideline study

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for acute toxicity is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for acute toxicity is not warranted under Regulation (EC) No.1272/2008.