Castor oil, ethoxylated

Endpoint summary

Description of key information

The skin sensitization potential of test chemical was assessed in various experimental studies conducted on guinea pigs. Based on the available data for the target and supporting studies, it can be concluded that the test chemical is unable to cause skin sensitization and thus can be considered as not sensitizing. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Not Classified”.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Guinea pig maximization test

Principles of method if other than guideline:

Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical

GLP compliance:

not specified

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Currently no LLNA study is available for assessment. The Guinea Pig Maximization Test (GPMT) has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: IffaCredo, l'Arbresle, France
- Weight at study initiation: 300 to 400 g
The guinea pigs were maintained under standard test conditions

Route:

intradermal

Vehicle:

unchanged (no vehicle)

Concentration / amount:

two intradermal injections of Freund's complete adjuvant
10 repeated intradermal applications of the substance (0.5 ml per animal)

Day(s)/duration:

no data available

Adequacy of induction:

not specified

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5 ml

Day(s)/duration:

48 h

Adequacy of induction:

not specified

No.:

#1

Route:

epicutaneous, occlusive

Vehicle:

unchanged (no vehicle)

Concentration / amount:

0.5ml

Day(s)/duration:

48 hours

Adequacy of challenge:

other: guineapigs were challenged on the abdomen, using the maximum dose which had not caused any orthoergic skin reaction in preliminary studies

No. of animals per dose:

Groups of 10 male and female guinea pigs.

Details on study design:

RANGE FINDING TESTS: no data available

MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal exposure
- No. of exposures: 10
- Exposure period: no data available
- Test groups: 10
- Control group: no data available
- Site: back
- Frequency of applications: 2 intradermal injections of FCA, 10 repeated intradermal applications of the substance (0.5 ml per animal)
- Duration: 48 hours
- Concentrations: 2 intradermal injections of FCA, 10 repeated intradermal applications of the substance (0.5 ml per animal)

Epicutaneous, Occlusive exposure
- No. of exposures: single
- Exposure period: no data available
- Test groups: 10
- Control group: no data available
- Site: back
- Frequency of applications: single
- Duration: 48 hours
- Concentrations: 0.5 ml


B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge:
- Exposure period: no data available
- Test groups: 10
- Control group:
- Site: abdomen
- Concentrations: Guineapigs were challenged on the abdomen, using the maximum dose which had not caused any orthoergic skin reaction in preliminary studies, 0.5 ml
- Evaluation (hr after challenge): 48 hours

OTHER: The macroscopic cutaneous response was evaluated, according to a classical scale for erythematous and oedematous lesions (Draize, Woodgard and Calvery, 1944). The macroscopic
examination was negative (no allergy) when the score was equal to or less than the score obtained following the first intradermal application. Otherwise, the examination was considered doubtful and a histological examination was undertaken to obtain specific evidence of an allergic reaction, such as skin infiltration with lymphocytes and plasmocytes.

Challenge controls:

no data available

Positive control substance(s):

not specified

Reading:

1st reading

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 ml

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

The test chemical was found to be deviod of sensitizing capacity

Remarks on result:

no indication of skin sensitisation

Table: Skin-sensitizing potential of Althesin and its constituents in guinea pigs. Doses per animal used for challenge were 0.5 ml for the test chemical.

This dose was the maxima which did not cause any orthoergic response in preliminary studies

Substance	Macroscopic examination (% doubtful)	Histological examination (% positive)	Conclusion
Test chemical
Female	50	0	Not sensitizing
Male	60	0	Not sensitizing

Interpretation of results:

other: not sensitizing

Conclusions:

The test chemical was found to be deviod of sensitizing capacity 48 hours after challenge exposure.
Hence, the test chemical was considered to be not sensitizing to skin.

Executive summary:

Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical.

Groups of 10 male and female young adult Dunkin Hartley guinea pigs were used for the study.All animals were submitted to an intradermal sensitization test, performed with two intradermal injections of Freund's complete adjuvant.

During the induction period, 10 repeated intradermal applications of the substance (0.5 ml per animal) were performed on the skin on the back of the guineapigs. An occlusive bandage was applied for 48 h. After a 12-day rest period, guineapigs were challenged on the abdomen, using the maximum dose which had not caused any orthoergic skin reaction in preliminary studies. Doses per animal used for challenge were 0.5 ml for the test chemical. This dose was the maxima which did not cause any orthoergic response in preliminary studies.

Fortyeight hours later, the macroscopic cutaneous response was evaluated according to a classical scale for erythematous and oidematous lesions.The macroscopic examination was negative (no allergy) when the score was equal to or less than the score obtained following the first intradermal application, otherwise the score was considered as doubtful and a histological examination was performed to obtain the specific evidence of skin sensitization.

The test chemical was found to be deviod of sensitizing capacity 48 hours after challenge exposure.

Hence, the test chemical was considered to be not sensitizing to skin.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Various studies were performed on guinea pigs to assess the dermal sensitization potential of Test chemical. The studies are summarized as follows:

The Guinea pig maximization test was performed to evaluate the dermal sensitization potential of the test chemical. Groups of 10 male and female young adult Dunkin Hartley guinea pigs were used for the study. All animals were submitted to an intradermal sensitization test, performed with two intradermal injections of Freund's complete adjuvant. During the induction period, 10 repeated intradermal applications of the substance (0.5 ml per animal) were performed on the skin on the back of the guinea pigs. An occlusive bandage was applied for 48 h. After a 12-day rest period, guinea pigs were challenged on the abdomen, using the maximum dose which had not caused any orthoergic skin reaction in preliminary studies. Doses per animal used for challenge were 0.5 ml for the test chemical. This dose was the maxima which did not cause any orthoergic response in preliminary studies. Fortyeight hours later, the macroscopic cutaneous response was evaluated according to a classical scale for erythematous and edematous lesions. The macroscopic examination was negative (no allergy) when the score was equal to or less than the score obtained following the first intradermal application, otherwise the score was considered as doubtful and a histological examination was performed to obtain the specific evidence of skin sensitization. The test chemical was observed to be devoid of sensitizing capacity 48 hours after challenge exposure. Hence, the test chemical was considered to be not sensitizing to skin.

 

The above results was supported by a sub-cutaneous skin sensitization study which carried out to evaluate the dermal sensitization potential of the test chemical. During the study, 10 daily injections wi th 0.1% test chemical (1*0.05 mL; 9*0 .1 mL ) were administered to guinea pigs (number not specified ) on their backs. After a rest period of 13 days, the guinea pigs were challenged with 0.05 ml of 0.1% test chemical injection on the neck. The treated sites were observed for signs of irritation and sensitization through out the study period. Reddening occurred around the injection sites during induction ,but no sign of sensitization was present. Hence, the test chemical was considered to be not sensitizing to skin when exposed sub-cutaneously.

 

The above results were further supported by another maximization study conducted to assess the dermal sensitization potential of the test chemical. The flanks of 10 guinea pigs were shaved, degreased with ether, and 50% test chemical was applied to the left flank of each animal(painted 3 times sequentially with a saturated cotton swab) for 10 consecutive days. The right flank were left untreated and served as control. After a rest period of 12 days, 5% test chemical in acetone was applied to the right flank (after degreasing with ether). The skin was observed for signs of irritation after 12 hours. A control group of 3 guinea pigs was untreated during the induction phase of the experiment but was given a single application of 5% test chemical. Slight reddening of the skin was observed during the induction phase but no signs of irritation were observed after the challenge exposure. Hence, the test chemical was considered to be not sensitizing to skin.       

 

All these studies lead to a conclusion that test chemical is indeed not sensitizing to skin. Hence, comparing the above annotations with the criteria of CLP regulation, Test chemical can be classified under the category “Not Classified”.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

The skin sensitization potential of test substance was observed in various experimental studies. From the results obtained from these studies it is concluded that the chemical is not likely to cause skin sensitization and hence can be classified as non-skin sensitizer.