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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 - 20 Dec 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (Dec 2012)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Justification for type of information:
refer to category justification provided in IUCLID section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Clerco Research Farm, USA
- Weight at study initiation: 2870-2915 g (males), 2746-3057 g (females)
- Housing: individually in suspension cages with wire mesh floors
- Diet: PURINA Laboratory Rabbit Chow, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: the test substance was held in contact with the skin using a porous gauze dressing secured with tape.

REMOVAL OF TEST SUBSTANCE
- Washing: the test substance was removed with a moistened towel
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount applied: 2000mg/kg bw: 4.9-5.1 mL (males) and 4.8- 5.3 mL (females)
- Dose factor: 1.74 mL/kg


Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for signs of toxicity and behavioural changes. Individual body weights were determined prior to treatment, on Day 7 and prior to necropsy.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
For body weights, mean values and standard deviations were calculated.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
Partly hunched posture and slight depression occurred during the observation period.
Body weight:
No treatment-related changes.
Gross pathology:
No treatment-related changes.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
CLP: not classified

In conclusion, under the conditions chosen for this acute dermal toxicity study conducted according to OECD 402 at the limit concentration of 2000 mg/kg bw no severe clinical signs of toxicity or mortalities were observed. Therefore, the test substance does not need to be classified according to Regulation (EC) No 1272/2008.