Registration Dossier

Administrative data

Description of key information

The test article is considered as sensitiser.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Remarks:
in vivo test
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Study period:
From February, 14 to April, 21 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A non-LLNA skin sensitisation study does not need to be conducted because adequate data from an in vivo study are available.
Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CIBA-GEIGY Limited Animal Production
- Weight at study initiation: 339 to 404 g
- Housing: The animals were housed individually in Macrolon cages (Type 3)
- Diet: The animals received ad libitum standard guinea pig pellets NAFAG No. 845, All batches of the diet are assayed for nutritive ingredients and contamination level
- Water: fresh water ad libitum. The drinking water quality fulfilled the critical parameters in the specifications of the "Schweizerisches Lebensmittelbuch" (Edition 1972). The results of the routine chemical examination of water a t source (Grundwasserfassung Stein) as conducted periodically by the water authority (Baudepartement des Kantons Aargau, Abteilung Gewaesserschutz)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours light cycle day.
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
30% in physiological saline (0.2 g)
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30% in physiological saline (0.2 g). No with. + reactions: 8.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
30% in physiological saline (0.2 g)
No. with + reactions:
8
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 30% in physiological saline (0.2 g). No with. + reactions: 8.0. Total no. in groups: 20.0.

The individual animal body weights were measured at the start and at the end of the test. Body weights were not affected by treatment.

Interpretation of results:
Category 1B (indication of skin sensitising potential) based on GHS criteria
Conclusions:
Sensitizer
Executive summary:

The study was conducted according to OECD Guideline 406, Guinea Pig Maximisation test. Ten animals (5 male and 5 female) were exposed to test article and 5 Guinea Pig were used as control. During the Intradermal induction the animals were exposed to test article at a concentration of 5 %. During the challenge after 24 and 48 hours 40 % of the treated animals showed a positive reaction to the test item. Based on these positive reaction the test article is considered as sensitizer for Guinea pig.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

Test on skin sensititation is available on similar substance 1.

The complete hypothesis and justification for the read across approach has been attached in section 13.

The assessment was based on a single study (Huntsman, 1994) conducted according to OECD Guideline 406, Guinea Pig Maximisation test. Ten animals (5 male and 5 female) were exposed to test article and 5 Guinea Pig were used as control. During the Intradermal induction the animals were exposed to test article at a concentration of 5 %. During the challenge after 24 and 48 hours 40 % of the treated animals showed a positive reaction to the test item.


Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC n. 1272/2008): Skin sensitiser means a substance that will lead to an allergic response following skin contact.

Sub- category 1B: Substances showing a low to moderate frequency of occurrence in humans; or a probability of occurrence of a low to moderate sensitisation rate in humans based on animal or other tests. More specifically, as reported in the Table 3.4.4, a substance shall be classified as Sub category 1B if, in a Guinea pig mazimisation test, the tested animals showed a skin reaction in a percentage ≥ 30 % responding at > 1 % intradermal induction dose

Under the experimental conditions employed, 40 % of the treated animals showed skin reactions responding at an intradermal induction dose of 5 %.

According to the CLP Regulation (EC n. 1272/2008) the substance has met the criteria for classification as Skin sensitisation Category 1B.