Palmitoyl chloride

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Palmitoyl chloride

EC Number:

203-996-7

EC Name:

Palmitoyl chloride

Cas Number:

112-67-4

Molecular formula:

C16H31ClO

IUPAC Name:

hexadecanoyl chloride

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Janvier Labs, France
- Age at study initiation: young adult (female approx. 9-10 weeks)
- Weight at study initiation: animals of comparable weight (+/- 20% of the mean weight)
- Housing: Makrolon cage, type III (single housing)
- Diet (e.g. ad libitum): LASQCdiet® Rod16, HiHyg, LASvendi (Altromin, 32791 Lage, Germany)
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days before experimental phase

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22  3°C
- Humidity (%): 30-70 %
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12 h

Administration / exposure

Type of coverage:

semiocclusive

Vehicle:

corn oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 40cm²
- % coverage: 10%
- Type of wrap if used:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

Duration of exposure:

24 h

Doses:

- 1000 mg/kg bw (main and range finder study
- 2000 mg/kg bw (range finder study)

No. of animals per sex per dose:

2 (main study)
1 (range finder study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter
- Necropsy of survivors performed: yes
- Clinical signs including body weight
- Other examinations performed: clinical signs, body weight, pathology

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 1 000 - < 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred in both animals.

Clinical signs:

other: No systemic clinical signs were observed in both animals during clinical examination. Local effects: In the first animal, moderate erythema (grade 3) was observed from study day 1 until study day 3, followed by well-defined erythema (grade 2) from study d

Gross pathology:

No macroscopic pathologic abnormalities were noted in any animal examined on the last day of observation (4 females).

Any other information on results incl. tables

Range finding study

Mortality: In the first range finding study dosed with 2000 mg/kg bw, the animal was sacrificed moribund due to severe skin findings and resulting distress on day 7 after administration. No mortality occurred in the second range finding study dosed with 1000 mg/kg bw.

Systemic effects: No obvious systemic clinical signs were observed during clinical examination, but distress due to the observed skin findings must be considered.

Local effects: In the first range finding study with 2000 mg/kg bw, severe erythema (grade 4) was seen in the single animal from study day 1 until day 7, while slight edema (grade 2) was noted from study day 2 until day 7. In addition, incrustation was observed on study day 3, followed by oozing wounds from study day 6 until study day 7. In the second range finding study with 1000 mg/kg bw, the single animal showed moderate erythema (grade 3) from study day 1 until day 2, followed by well-defined erythema (grade 2) from study day 3 until day 12 and very slight erythema (grade 1) from study day 13 until 14. In addition, eczema was seen from study day 1 until study day 2, while incrustation was noted from study day 3 until study day 14. Erythema and incrustation beyond the application area were noted from study day 7 until study day 14.

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study the median lethal dose (LD50) of palmitoyl chloride after dermal application was assessed to be greater than 1000 mg/kg bw and lower than 2000 mg/kg bw in female rats.