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Diss Factsheets

Administrative data

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.