Caramel (color)

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:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

without impact on the study conclusion (A temperature higher than 25°C was registered on a day. The maximum value measured was 27°C.)

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Caramel (color)

EC Number:

232-435-9

EC Name:

Caramel (color)

Cas Number:

8028-89-5

Molecular formula:

C6H12OH

IUPAC Name:

Caramel

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

female

Details on test animals or test system and environmental conditions:

Three Sprague Dawley rats (SPF Caw) were used after an acclimatisation period of at least five days. The animals were nulliparous and non-pregnant. At the beginning of the study, the animals of the treated groups were 8 weeks old. They were identified prior to inclusion in the test by means of a numbered ring on the edge of one ear.

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. The temperature and relative humidity of the main test were controlled to remain within target ranges of 19°C to 25°C and 30% to 70%, respectively. The rate of air exchange was at least ten changes cycles per hour and the lighting was controlled by a time switch to give twelve hours continuous light (07.00 to 19.00) and twelve hours darkness.

Food and drink: Drinking water and foodstuff were supplied ad libitum. Microbiological and chemical analyses of the water were carried out once every six months.

Examinations of the animals
-Daily examination: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions during 14 days following the administration of the test item. This examination focuses particularly on a list of symptoms, recorded as "present" or "absent" on the observation sheet. These observations were compared to historical control data. Observations and a mortality report were then carried out every day for 14 days.
-Periodical examinations: The animals were weighed on day 0 (just before administering the test item) then on day 2, day 7, and on day 14. Weight changes were calculated and recorded.
-Examination at the end of the test: On D14, the animals were sacrificed with sodium pentobarbital (Dolethal®). Macroscopic observations were entered on individual autopsy sheets. Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.

Administration / exposure

Type of coverage:

open

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animals by clipping. At least 10 per cent of the body surface area was clear for the application of the test item CARAMEL COLOUR E150c.
Animals from treated group received by topical application, under non occlusive porous gauze dressing secured in position with a strip of surgical adhesive tape, an effective dose of 2000 mg/kg body weight administered under a volume of 1.51 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated area was rinsed with distilled water.

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

2 female rats receivent caramel at dose 2000 mg/kg bw.

Control animals:

no

Details on study design:

A preliminary study (range-finding study) was performed. Approximately 24 hours before the treatment, fur was removed from the dorsal area of the trunk of the test animal by clipping. At least 10 per cent of the body surface area was clear for the application of the test item CARAMEL COLOUR E150c. The animal received by topical application, under non occlusive porous gauze dressing secured in position with a strip of surgical adhesive tape, an effective dose of 2000 mg/kg body weight administered under a volume of 1.51 mL/kg body weight, during 24 hours. After 24-hour exposure period, the gauze dressings were removed and the treated area was rinsed with distilled water.

Results and discussion

Preliminary study:

At the dose of 2000 mg/kg bw, in the animal tested:
No mortality occurred during the study.
Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.
The body weight evolution of the animals remained normal throughout the study.
The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

no indication of skin irritation up to the relevant limit dose level

Mortality:

No mortality occurred during the study.

Clinical signs:

other: Neither cutaneous reactions nor systemic clinical signs related to the administration of the test item were observed.

Gross pathology:

The macroscopic examination of the animals at the end of the study did not reveal treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 of the test item CARAMEL COLOUR E150c is higher than 2000 mg/ kg body weight by dermal route in the rat. The test item CARAMEL COLOUR E150c does not have to be classified in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
No signal word or hazard statement is required.