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Toxicological information

Acute Toxicity: dermal

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Administrative data

acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
05 November 2019 - 21 November 2019
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 402 (Acute Dermal Toxicity)
A relative humidity lower than 30% was registered on 19 and 20 November 2019. The minimum value measured was 25%. As no effect was noted on the health of the animals, this deviation is considered as without impact on the conclusion of the study.
GLP compliance:
yes (incl. QA statement)
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Test material form:

Test animals

(SPF Caw)
Details on test animals or test system and environmental conditions:
- Source: Elevage JANVIER LABS (53940 Le Genest St Isle – France)
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 207.7 g (SD = 6.7 g)
- Fasting period before study: not specified.
- Housing: During the treatment, the animals were kept in individual cages. On D1, the animals were put together into their cage. The rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid. Each cage contains dust free wood shavings which were changed at least 2 times a week. Each cage was installed in conventional air conditioned animal husbandry.
- Diet (e.g. ad libitum): Ad libitum. Teklad Global 16% Protein Rodent Diet (ENVIGO 2016).
- Water (e.g. ad libitum): Ad libitum. Drinking water (tap-water from public distribution system). Microbiological and chemical analyses of the water were carried out once every six months by Bureau Veritas – Eurofins (FRANCE).
- Acclimation period: the animals were acclimatized for at least 5 days before treatment.

- Temperature (°C): 19ºC to 25ºC
- Humidity (%): 30 to 70%
- Air changes (per hr): ≥10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light (07.00 to 19.00) and 12 hours dark cycle.

Administration / exposure

Type of coverage:
unchanged (no vehicle)
Details on dermal exposure:
- Area of exposure: dorsal area of the trunk
- % coverage: at least 10% of the body surface area.
- Type of wrap if used: porous gauze dressing (50 mm x 50 mm non-woven swab of 4-layer patch from MEDISTOCK) secured in position with a strip of surgical adhesive tape (50 mm wides hypoallergenic microporeTM adhesive tape from 3M).

- Washing (if done): no
- Time after start of exposure: 24h

- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight
- Concentration (if solution): N/A
- Constant volume or concentration used: 2.43 mL/kg body weight (based on 0.835 relative density and 98.5% purity)
- For solids, paste formed: N/A
Duration of exposure:
24 h
Range finding study: 2000 mg/kg body weight
Main study: 2000 mg/kg body weight
No. of animals per sex per dose:
Range finding study: 1 female per dose
Main study: 2 females per dose
Control animals:
(study performed on three females receiving distilled water by topical application under requirements of OECD Guideline 402)
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: At each step, the animals were observed three times on test day 0 (day of administration), i.e. at T0+30 min, T0+3h and T0+5h, and once daily during days 1 to 14 post administration. The body weights were recorded on test day 0 (just before administration) then on D2, D7, and D14.
- Necropsy of survivors performed: yes. At termination, gross pathological findings were recorded and reported.
- Other examinations performed:
Clinical observations: spontaneous activity, Preyer’s reflex (noise), respiratory rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex and treatment site (erythema, dryness of the skin, scab, etc.)

Results and discussion

Effect levels
Key result
Dose descriptor:
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
No mortality occurred during the study.
Clinical signs:
other: No systemic clinical signs related to the administration of the test item were observed. Erythema was noted in treated animals (3/3) between Days 1 and 7. This reaction was associated with dryness of the skin (3/3) between Days 3 and 12 and scab (3/3) bet
Gross pathology:
The macroscopic examination of the animal at the end of the study did not reveal treatment-related changes.

Any other information on results incl. tables

Table 1: Body weight and weight gain in grams

Females D0 D2 D2-D0 D7 D7-D0 D14 D14-D0
Rf4434 212 205 -7 218 6 232 20
Rf4435 200 200 0 210 10 220 20
Rf4436 211 207 -4 226 15 237 26
MEAN 207.7 204.0 -3.7 218.0 10.3 229.7 22.0
S.D. 6.7 3.6 3.5 8.0 4.5 8.7 3.5

Applicant's summary and conclusion

Interpretation of results:
other: No category (CLP Regulation EC no. 1272/2008)
The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats.

Executive summary:

The acute dermal toxicity of the test item was studied according to OECD Guideline 402 (GLP study). 3 female Sprague-Dawley rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted at a single dose of 2000 mg/kg bw in one animal. Based on the results of range finding two additional rats were tested at a dose of 2000 mg/kg bw. No mortality was observed. The body weight evolution of the animals remained normal during the study. Erythema was noted in treated animals (3/3) between days 1 and 7. This reaction was associated with dryness of the skin (3/3) between days 3 and 12 and scab (3/3) between days 3 and 8. The skin recovered a normal aspect at day 13. No other clinical signs were observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. Based on these results, the test item was found to be non toxic, with an LD50 > 2000 mg/kg bw.