Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A scientifically sound study but no individual data, no necroscopy or histological data.

Data source

Reference
Reference Type:
publication
Title:
Comparative percutaneous toxicity of ten industrial solvents in the guinea pig
Author:
Wahlberg, J., E.; Boman, A.;
Year:
1979
Bibliographic source:
Scand. j. work environ. & health, vol. 5, p. 345-351

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
0.5 and 2.0 mL of CTC were applied to guinea pigs weighting 372 ± 3 g (low dose group) and 373 ± 5 g (high dose group) to a covered skin depot; the mortality rate was determined after an observation period of 35 d
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): carbon tetrachloride
- Physical state: not reported
- Analytical purity: p. a.
- supplier: Merck, Darmstadt, Germany
- Stability under test conditions: not reported
- Storage condition of test material: not reported

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: not reported
- Age at study initiation: not reported
- Weight at study initiation: 372 ± 3 g low dose group, 373 ± 5 g high dose group
- Fasting period before study: not reported
- Housing: in groups of three in Makrolon cages
- Diet (e.g. ad libitum): standard laboratory animal food (Astra Ewos, Sodcttalje, Sweden), ad libitum
- Water (e.g. ad libitum): water supplemented with ascorbic acid, ad libitum
- Acclimation period: not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 3.1 cm x cm
- % coverage: 0.7 %
- Type of wrap if used: A glass ring, 20 mm in inner diameter (area: 3.1 cm x cm), 4 mm in thickness, and 10 mm in height, glued on with a-cyanoncrylate glue and covered with a glued on glass cover slip (with a hole in the center to apply the substance with was finally covered with small piece glued to the cover glass).
- control animals were treated with distilled water

REMOVAL OF TEST SUBSTANCE
- Washing (if done): substance was completely absorbed
- Time after start of exposure: substance was completely absorbed


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.0 and 0.5 ml pure substance



VEHICLE
- none used
Duration of exposure:
- until substance was absorbed
Doses:
- 0.5 and 2.0 ml (= 0.792 and 3.17 g, on average 2130 and 8500 mg/kg bw)
No. of animals per sex per dose:
20 per dose, sex not indicated
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 35 days

- Frequency of weighing: daily, but not reported
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no
Statistics:
- no statictic analysis conducted

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
approximate LD50
Effect level:
>= 2 130 - <= 8 500 mg/kg bw
Mortality:
after 14 days: 2130 mg/kg bw 5/20
8500 mg/kg bw 12/20
after 35 days: 2130 mg/kg bw 5/20
8500 mg/kg bw 13/20
Clinical signs:
- not analyzed
Body weight:
- not reported
Gross pathology:
- not analyzed

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: According to EU directive 67/548/EEC and EU Regulation (EC) N0. 1272/2008 (CLP)
Conclusions:
From the present study (Wahlberg, 1979) the LD50 (guinea pig, dermal) can be approximated to lie between 2130 and 8500 mg/kg bw. in guinea pig.
Executive summary:

The potential of the test substance CTC (named carbon tetrachloride in the study report) to induce acute dermal toxicity was evaluated in a study following no official guideline. Guinea pigs, unspecified concerning sex and strain, were treated with the test substance on the clipped skin under a special occlusive device and were observed for 35 days for mortality and body weight only, but the body weight development was not reported. No pathological or histological analysis were conducted.

Treatment with the the test substance resulted in mortalities of 25 % at 2130 mg/kg bw and 65 % at 8500 mg/kg bw after 35 d of observation with a biphasic occurence with peaks between days 2 -4 and between days 7 -14. As only two concentration were tested the LD50 could only be approximated to lie between the two tested doses. The approximated LD50 was derived to be >2000 mg/kg bw.