Reaction mass of 2,6-Bis[(dimethylamino)methyl]-4-(1-{3-[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)phenol and 4-(1-{3,5-Bis[(dimethylamino)methyl]-4-hydroxyphenyl}-1-methylethyl)-2,6-bis[(dimethylamino)methyl]phenol

Endpoint summary

Description of key information

The acute toxicity of HPP 12879 -1 in rats is > 2000 mg/kg bw (LD50) after dermal administration (Haferkorn, 2016).

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no study available

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:

March to April 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, dry

Species:

rat

Strain:

other: CD / Crl: CD(SD)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, 97633 Sulzfeld, Germany
- Age at study initiation: approx. 8 weeks (males); approx. 9 weeks (females)
- Weight at study initiation: 252 - 270 g ( males); 224 - 251 g (females)
- Housing: During the 14-day observation period the animals were kept singly in MAKROLON cages (type III plus)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): no data available
- Photoperiod (hrs dark / hrs light): 12/1

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Statistics:

none: limit test

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: At patch removal after exposition the epidermis under the test item was detached. The affected area was bloodless. Since test day 3 all lesions were covered with scab.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

Necropsy revealed scarred application sites and/or application sites covered with scab.

Executive summary:

An acute dermal toxicity study was performed according to OECD TG 402. 2000 mg/kg of the test item was applied occlusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development were observed during the 14 -days observation period. At patch removal after exposition the epidermis under the test item was detached. The affected area was bloodless. Since test day 3 all lesions were covered with scab. Necropsy revealed scarred application sites and/or application sites covered with scab. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Quality of whole database:

The study is GLP compliant and is of high quality (Klimisch score=1)

Additional information

An acute dermal toxicity study was performed according to OECD TG 402 (Haferkorn, 2016). 2000 mg/kg of the test item was applied occlusive on 5 male and 5 female rats for 24 hours. No mortalities, no clinical signs, no effects on weight development were observed during the 14 -days observation period. At patch removal after exposition the epidermis under the test item was detached. The affected area was bloodless. Since test day 3 all lesions were covered with scab. Necropsy revealed scarred application sites and/or application sites covered with scab. The resulting LD50 was therefore > 2000 mg/kg bw for both sexes combined.

Justification for classification or non-classification

Acute toxicity: dermal

Based on the LD50 > 2000 mg/kg bw a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.